Moorfields Bleb Grading System Research Articles

The Effects of Bevacizumab in Augmenting Trabeculectomy for Glaucoma : Systematic Review and Meta-Analysis

Introduction & Objectives : Anti-vascular endothelial growth factor (VEGF) agents have been used to slow the healing response and postoperative scar tissue formation. To determine the effectiveness of adding Anti VEGF bevacizumab to the results of trabeculectomy in glaucoma.
 Methods : Searches were conducted in a structured way using keywords across several data sources, including Pubmed, Proquest and Cochrane library. The keywords used for searching were “Bevacizumab”, “Trabeculectomy” and “Glaucoma”. The reviewed articles are Randomized Control Trial in english, conducted on humans in the last 15 years. The review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
 Results : From a total of 353 articles, there were 6 studies with 362 eyes of 352 patients been evaluated for the effectiveness of bevacizumab addition to trabeculectomy. The primary outcome of all articles was the assessment of Intra Ocular Pressure (IOP). No significant difference in IOP was found between the subconjunctival bevacizumab + Mytomycin-c group and mytomycin-c alone group (MD 0.11 ; 95% CI -0.10 to 0.33), as well as subconjunctival comparison with mytomycin-c (MD 0.11 ; 95% CI -0.29 to 0.50). Similar results were also found in the intracameral and placebo groups (MD 0.08 ; -0.22 to 0.38). However, 3 articles reported significant differences in peripheral vascularity of the bleb both by the Moorfields Bleb Grading System and by the Indiana Bleb Appearance System.
 Conclusion : The addition of bevacizumab to trabeculectomy did not show any benefit in reducing IOP when compared with MMC. But it gives better peripheral vascularity of the bleb.

Filtering Bleb Characteristics in Combined Cataract Surgery with Ex-PRESS Implant vs. Non-Penetrating Deep Sclerectomy. A Prospective, Randomized, Multi-center Study

(1) Background: After filtering surgery, bleb morphology is an indicator of the factors that may determine the final intraocular pressure (IOP). The present study aimed to evaluate and compare filtering bleb characteristics after combined cataract and glaucoma surgery. (2) Methods: We conducted a prospective multi-center randomized trial. Eyes with glaucoma and cataract were randomly assigned to either phacoemulsification and filtration surgery with an EX-PRESS implant (Alcon) or non-penetrating deep sclerectomy (NPDS) with an ESNOPER implant (AJL). The bleb characteristics were assessed with the Moorfields bleb grading system at months 1 and 12 of follow-up, and the relationship with IOP was analyzed. (3) Results: There were significant changes in bleb appearance between the assessments at month 1 and month 12. The changes in bleb appearance were more evident in the EX-PRESS group. The central area in the EX-PRESS group decreased from 2.9 at month 1 to 2.4 at month 12 (p = 0.014). Bleb height in the EX-PRESS group decreased from 2.3 at month 1 to 1.8 at month 12 (p = 0.034). The vascularity of the central area in the NPDS group decreased from 1.8 at month 1 to 1.3 at month 12 (p = 0.02). The maximal bleb area was inversely related (r = −0.39; p = 0.03) to the IOP in the NPDS group at month 1. Vascularity in the central area was directly related (r = 0.39; p = 0.01) to a higher IOP in the EX-PRESS group at month 1. Vascularity in the central area (r = 0.56; p < 0.001) and maximal area (r = 0.37; p = 0.012) at month 1 was directly related to a higher IOP in the EX-PRESS group at month 12. (4) Conclusions: More intense vascularity at month 1 was related to a higher final IOP in the EX-PRESS group. Larger blebs were associated with a lower IOP in the NPDS group.

Assessing safety and success after using bevacizumab, 5-fluorouracil or placebo in primary trabeculectomy. A prospective randomized placebo controlled 1-year follow-up study

Purpose The aim of this study was to determine whether glaucoma patients after trabeculectomy could benefit more from subconjunctival injections of bevacizumab than 5-FU or placebo. Methods and results Fifty-one eyes of 51 patients were recruited for primary MMC (0.2 mg/mL for 1 min) augmented trabeculectomy. 17 patients were randomly assigned to receive 1.25 mg (0.05 mL) of bevacizumab augmentation, 21 patients were assigned to receive 0.1 mL of 50 mg/mL 5-FU and 13 patients were assigned to a control group receiving a normal saline injection as a placebo. Initial recruitment included 58 patients, but seven patients had to be excluded from the study for various reasons. Postoperative follow up of IOP and bleb characteristics was carried out at 1 day, 1 week, 3 weeks, 6 weeks, 6 months and 1 year after surgery. All analyses where carried out by two masked clinicians. IOP reduction was statistically significant (p < 0.05) across all three groups between baseline visit and final 1-year postoperative visit. There was no significant difference of the final average IOP values between the three groups. Bleb evaluation was made using the Moorfields bleb grading system (MBGS) after 1 year follow up. Central bleb area was statistically greater in the Bevacizumab group when compared with the 5-FU group but not with the placebo group. The vascularity of the central bleb was significantly different between the groups with the Bevacizumab group showing the least vascularity. Vascularity of the peripheral bleb was also decreased in the Bevacizumab group when compared with the placebo group but not with the 5-FU group. Conclusion The 12-month IOP results showed no significant differences between the groups of patients after Bevacizumab, 5-FU or placebo to augment primary MMC enhanced trabeculectomy. However, by the analysis of bleb morphology there was a significant difference in terms of central bleb area and vascularity.

Adjunctive modulation of wound healing during cataract surgery to promote survival of a previous trabeculectomy.

Trabeculectomy is a surgical treatment for glaucoma to lower intraocular pressure with high success rates; however, it is often associated with an increased rate of cataract formation. Cataract can cause symptoms such as glare in bright conditions, foggy vision, and difficulty in driving at night. Cataract extraction surgery is highly successful in improving vision, but it comes at a cost of trabeculectomy failure, with a reported risk of 30% to 40%. An additional intervention to promote trabeculectomy survival after cataract extraction is needed. This review encompassed all adjunctive therapies used at the time of cataract surgery to increase trabeculectomy survival rate. To investigate the effect of the adjunctive modulation of wound healing during cataract surgery on the survival of a previously functioning trabeculectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 4); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov; and the WHO ICTRP. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 14 April 2021. We plannedto include all randomised controlled trials (RCTs)of participants who had a functioning trabeculectomy and were undergoing cataract surgery that compared any adjunctive therapy intended to modulate wound healing (such as 5-fluorouracil, mitomycin C, or anti-vascular endothelial growth factor (VEGF) therapy) with no adjuvant therapy. DATA COLLECTION AND ANALYSIS: We used standard methods expected by Cochrane. Our primary outcome wastrabeculectomy failure at 6 months and 12 months after cataract surgery. Secondary outcomes weremean intraocular pressure difference from pre-cataract surgery baseline to 6 to 18 months post-cataract surgery; number of medications required to control eye pressure compared to before cataract surgery; bleb appearance as measured by a summation score of the Moorfields bleb grading system or other equivalent numerical grading systems; visual field progression measured by difference in mean deviation from baseline; and any complications. We did not identify any RCTs of adjunctive modulation of wound healing during cataract surgery to promote survival of a previous trabeculectomy. There is a need for an RCT to investigate the role of adjuvant wound modulating therapy at the time of cataract surgery to promote survival of a functioning trabeculectomy.

Changes in the morphology of the hyperemic blebs in eyes undergone trabeculectomy with mitomycin C after injection of triamcinolone acetonide during one-year follow-up.

To track changes in the morphology of hyperemic blebs in eyes undergone trabeculectomy with mitomycin C 0.02% (MMC) after triamcinolone acetonide (TA) injection. A total of 30 eyes of 30 patients with localized or diffuse hyperemia after trabeculectomy with MMC were enrolled in this prospective interventional case series. Two milligrams of TA were injected at the site of maximal injection. Bleb morphology was graded using Indiana Bleb Appearance Grading Scale (IBAGS), and the Moorfields Bleb Grading System (MBGS) 1week, 1month, 3months, 6months, and 1year after injection. Failure was defined as intraocular pressure (IOP) more than predefined target IOP for each eye, need for an additional surgical procedure, IOP less than 6mmHg, and loss of Light Perception (LP) vision. A total of 27 patients completed a 1-year follow-up period and were included in the final analysis. The mean time interval from trabeculectomy to injection of TA was 5.98 ± 2.57weeks. The bleb height and vascularity in the IBAGS system decreased significantly after the intervention (p < 0.05), with an increase in bleb extension (p = 0.006). Using MBGS, the bleb area did not change significantly following TA injection (p = 0.056) but its height and vascularity significantly decreased in both central and peripheral areas and the surrounding conjunctiva (p = 0.032). The development of a mature cataract was the only complication that could be attributed to TA injection. Injection of TA in hyperemic failing blebs improves bleb morphology by decreasing vascularity and height while increasing the extent with an acceptable safety profile.

Evaluation of Functional Filtering Bleb Using Optical Coherence Tomography Angiography.

PurposeThis study investigated whether filtering blebs can be evaluated using optical coherence tomography angiography (OCT-A) and compared vascularity parameters with conventional bleb grading systems.MethodsA total of 92 patients with glaucoma, who underwent mitomycin C–augmented trabeculectomy, were enrolled in this study, and 92 eyes were assessed in total. The participants underwent OCT-A in external mode and anterior segment photography for bleb evaluation. For evaluation of bleb vascularity, a blinded observer carefully drew the bleb area on the original OCT-A image using a semiautomated program that calculated the color and brightness densities of the selected area. A blinded observer also classified the grades of the bleb vessels using the Indiana Bleb Appearance Grading Scale (IBAGS) and Moorfields Bleb Grading System (MBGS). The vascularity parameters using OCT-A were compared with the IBAGS and MBGS results. In addition, the correlation between intraocular pressure (IOP) and the bleb vascularity parameters was assessed.ResultsVessel density measured by OCT-A demonstrated excellent inter- and intraobserver reproducibility. The color and brightness densities were positively correlated with the IBAGS and MBGS vascularity scores. There was no difference in accuracy when predicting IOP risk using vascularity scores from the IBAGS and MBGS or when estimating IOP risk using the color and brightness densities on the net reclassification index.ConclusionsBleb evaluation using OCT-A can evaluate vessel vascularity and showed correlation to the IBAGS and MBGS vascularity grading.Translational RelevanceBleb vascularity measurements using OCT-A could potentially provide objective and quantitative vessel parameters for bleb evaluation following trabeculectomy.

Phacotrabeculectomy using collagen matrix implant (Ologen® ) versus mitomycin C: a prospective randomized controlled trial.

To compare the efficacy and safety of collagen matrix implant (Ologen® ; OLO) with mitomycin C (MMC) in phacotrabeculectomy. Prospective, single-centre, nonblinded, randomized controlled trial. A total of 53 eyes of 45 patients were enrolled in the study protocol with 27 eyes randomly assigned to OLO and 26 to MMC. The follow-up was 12months. The primary outcome measure was mean change from baseline intraocular pressure (IOP) in both groups after 12months. The secondary outcome measures were cumulative success rates at 12months with Kaplan-Meier analysis, change in number of medications, change in best corrected visual acuity (BCVA), and bleb morphology assessed using Moorfields Bleb Grading System and anterior segment swept-source optical coherence tomography. The mean IOP decreased from 26.4±6.1mmHg to 13.7±3.8 in the OLO group and from 23.4±3.6mmHg to 13.3±2.8 in the MMC group at 1year without significant intergroup differences. At 1year, the overall success rates were 92.6% and 92.3% in the OLO and MMC groups, respectively. There were no significant differences in the overall success rates, BCVA, number of medications, morphology of the filtering blebs and rate of complications at the end of the follow-up. Ologen (OLO) provides similar surgical outcomes in phacotrabeculectomy compared with adjunctive MMC. It may be a new, safe and effective alternative to MMC for combined phacoemulsification and trabeculectomy surgery.

Trabeculectomy with Ologen versus Mitomycin C in Juvenile Open-Angle Glaucoma: A 1-Year Study

Background: We assessed bleb morphology and the intraocular pressure (IOP)-lowering effect of trabeculectomy with ologen compared to mitomycin C (MMC) in juvenile open-angle glaucoma (JOAG). Methods: This is a prospective interventional comparative study conducted on 40 eyes (20 patients) with medically uncontrolled JOAG, randomly operating one eye for trabeculectomy with ologen (group A: 20 eyes) and the other with MMC (group B: 20 eyes). IOP measurement, SITA standard perimetry, and spectral domain optical coherence tomography (OCT) for retinal nerve fiber layer (RNFL) thickness were all done pre- and postoperatively. Postoperative blebs were assessed clinically using the Moorfields bleb grading system (MBGS) and anterior segment OCT (AS-OCT). All patients were examined for up to 1 year postoperatively. Results: The mean postoperative IOP was statistically significantly lower than the mean preoperative IOP at each follow-up in each group. At 1 year, the mean postoperative IOP was significantly lower in group A. According to the MBGS, blebs with an ologen implant showed significantly better scoring than those with MMC. AS-OCT showed that ologen-induced blebs had significantly more fluid-filled spaces, cleavage planes, and less fibrosis. Conclusion: Ologen resulted in a lower long-term postoperative IOP, a better bleb morphology, and fewer complications. Our results suggest that ologen may be a useful alternative to MMC in JOAG.

Filtering blebs after XEN implantation and trabeculectomy: a clinical and in vivo confocal microscopy study

PurposeThe aim of this study was to evaluate and compare macroscopic and microscopic morphological features of functioning filtering blebs after XEN Gel Stent (XEN) implantation and trabeculectomy.MethodsProspective, observational case‐control study of 10 eyes submitted to XEN implantation, 10 eyes submitted to trabeculectomy and 11 control eyes treated medically. A complete ophthalmological examination was performed, including Goldmann applanation tonometry, slit‐lamp examination, anterior segment photography and in vivo confocal microscopy (IVCM – Heidelberg Retina Tomograph II, Rostock Cornea Module). Photographs were analyzed with Moorfields bleb grading system classification. The IVCM images were analyzed for the density of intraepithelial microcysts, the density of subepithelial connective tissue, the number, diameter and tortuousity of blood vessels and the presence of inflammatory cells. The examinations were performed from 6 to 16 months postoperatively and only blebs resulting from a surgery with total success were included (Intraocular pressure &lt;21 mmHg without therapy).ResultsThe analyze of anterior segment photographs didn't showed diferences between blebs's features after XEN implantation and trabeculectomy. The IVCM showed an increase in the density of intraepithelial microcysts and subepithelial connective tissue in XEN and trabeculectomy blebs comparing with the controls (p &lt; 0.05). All morphological findings were similar when comparing the group of XEN and trabeculectomy blebs.ConclusionsFunctioning blebs after XEN implantation showed similar features comparing with functioning blebs after trabeculectomy. Further longitudinal studies are needed to increase the postsurgery understanding and management of filtering blebs.

Efficacy of Bevacizumab Compared to Mitomycin C Modulated Trabeculectomy in Primary Open Angle Glaucoma: A One-Year Prospective Randomized Controlled Study

ABSTRACTPurpose: To compare the efficacy of bevacizumab over mitomycin C (MMC) modulated trabeculectomy in cases of primary open angle glaucoma (POAG).Method: In this prospective randomized controlled study, 80 eyes of 80 patients with uncontrolled POAG or intolerant to antiglaucoma medications were randomized to two groups: Group 1 (n = 40) patients underwent trabeculectomy modulated with MMC (0.2 mg/ml), whereas Group 2 (n = 40) patients underwent trabeculectomy modulated with bevacizumab (1.25 mg/0.05 ml). The outcome measures were best corrected visual acuity (BCVA), intraocular pressure (IOP), number of glaucoma medications and bleb morphological features based on Moorfields Bleb Grading System (MBGS). All patients were followed up for one year post trabeculectomy.Results: The mean preoperative IOP in the bevacizumab group improved from 22.41 ±1.08 mm Hg with 3.2 ± 0.9 glaucoma medications to 13.68 ± 0.79 mm Hg with 0.11 ± 0.32 glaucoma medications at one year (P < 0.001). The mean preoperative IOP in the MMC group improved from 22.64 ± 0.90 mm Hg with 3.1 ± 0.8 glaucoma medications to 13.84 ± 0.73 mm Hg with 0.17 ± 0.38 glaucoma medications at one year (P < 0.001). IOP was comparable between two groups at one year (P = 0.43). No significant differences were found in bleb morphological features based on MBGS regarding central bleb area, peripheral bleb area, height and central vascularity between the two groups at six months and one year. However, there was a statistically significant difference in peripheral bleb vascularity and peripheral non-bleb vascularity with bevacizumab group exhibiting a low degree of vascularity at one year (P = 0.029 and 0.004, respectively).Conclusion: Adjunctive bevacizumab in trabeculectomy is effective and comparable to MMC for controlling IOP in POAG patients for the first year.

Role of Subconjunctival Bevacizumab as an Adjuvant to Primary Trabeculectomy

To compare the safety and efficacy of primary trabeculectomy with adjunctive subconjunctival bevacizumab with that of primary trabeculectomy with mitomycin C (MMC). Forty-two patients with primary open-angle glaucoma were studied. Randomly, subject's eyes underwent primary trabeculectomy with either subconjunctival bevacizumab (2.5 mg/0.1 mL) or topical MMC (0.2 mg/mL for 3 min). The intraocular pressure (IOP) was the primary outcome measure. Secondary outcome measures included the corrected distance visual acuity, number of antiglaucoma medications, postoperative interventions and complications, bleb evaluation (on the basis of Moorfields Bleb Grading System), and the percentage of eyes achieving target pressure of 21, 18, 15, and 12 mm Hg at 6 and 12 months postoperatively. Of the 42 eyes, 21 treated with subconjunctival bevacizumab while 21 were treated with MMC. The mean preoperative IOP in the bevacizumab group improved from 23.9 ± 2.7 mm Hg with 2.6 ± 0.7 antiglaucoma medications to 13.9 ± 2.8 mm Hg with 0.6 ± 0.9 antiglaucoma medications at 12 months (P<0.001 and P<0.001, respectively). The mean preoperative IOP in MMC group improved from 22.9 ± 2.6 mm Hg with 2.7 ± 0.8 antiglaucoma medications to 12.2 ± 3.2 mm Hg with 0.1 ± 0.5 antiglaucoma medications at 12 months (P<0.001 and P<0.001, respectively). At 12 months, 15 of 21 (71%) eyes in the MMC group met a target IOP of 12 mm Hg without antiglaucoma medication while 7 of 21 (33%) eyes in the bevacizumab group did (P=0.02). Encapsulated bleb was seen in 2 (10%) patients in MMC group and in 6 (29%) patients in bevacizumab group (P=0.23). Although subconjunctival bevacizumab is effective and safe in primary trabeculectomy, IOP control appears to be superior with MMC, in terms of complete success with a target IOP<12 mm Hg and number of antiglaucoma medications required postoperatively.

Rosmarinic Acid Suppresses Subconjunctival Neovascularization in Experimental Glaucoma Surgery

Purpose: Excessive subconjunctival scarring is associated with increased angiogenesis and leads to filtration failure in glaucoma surgery. In this study, we describe that rosmarinic acid (RA) has anti-angiogenic activity during wound healing in a rabbit model of glaucoma surgery.Methods: Forty New Zealand rabbits underwent an experimental trabeculectomy and were randomly allocated into two treatment groups: RA group – treated with subconjunctival injections of 0.1 ml RA (15 mg/ml; n = 20) – and control group – treated with subconjunctival injections of 0.1 ml balanced salt solution (n = 20). The in vivo effect of RA was investigated after 5 and 15 d by measuring the intraocular pressure (IOP; with Tonopen) and bleb area and vascularity (using the Moorfields Bleb Grading System). Vascularization was also studied by counting histological blood vessels and by immunohistochemistry of vascular endothelial growth factor (VEGF) at the surgical site and by quantification of vessels in chicken’s chorioallantoic membrane (CAM), treated with AR 500 μg/ml for 48 h.Results: On the fifth day, eyes of RA group displayed higher bleb area (3.6 ± 0.2 versus 1.8 ± 0.2; p = 0.004) and lower vascularity (3.0 ± 0.5 versus 4.0 ± 0.4; p = 0.009) than controls; however, difference in IOP reduction was not significant (−1.4 ± 0.3 versus −0.8 ± 0.3 mmHg; p = 0.226). Proportion of vessels/field (4.6 ± 0.5 versus 10.4 ± 0.9; p = 0.008) and VEGF immunostaining (15,347 ± 3788 versus 31,043 ± 3230; p = 0.019) also declined with RA treatment. However, at the 15th day, none of the parameters were different between the groups, except for vessels/field proportion (5.4 ± 1.0 versus 10.6 ± 1.6; p = 0.035). CAM exposed to AR inhibited vascularization (−45.67 ± 4.74%; p < 0.001).Conclusion: These data indicate RA has a short-term anti-angiogenic effect and could be a potential modulator of neovascularization during subconjunctival healing at glaucoma filtration surgical sites.

Lysyl oxidase-like 2 level and glaucoma surgical outcomes.

To evaluate the levels of TGF-β and lysyl oxidases in both the aqueous humor and in Tenon's tissue in patients with POAG, and to assess their association with bleb morphological features and outcomes of glaucoma surgery. Eighteen POAG patients scheduled to undergo glaucoma surgery and 17 healthy controls were enrolled. At the time of surgery, approximately 0.1 mL aqueous humor through an anterior chamber paracentesis and a 4 × 4-mm sample of Tenon's tissue were obtained. Concentrations of TGF-β and lysyl oxidases (types 1 and 2) were analyzed by ELISA. The bleb morphologic features based on the Moorfields Bleb Grading System were evaluated by bleb photographs. The TGF-β in Tenon's tissue and lysyl oxidase-like 2 in aqueous humor and in Tenon's tissue were significantly elevated in POAG patients. When POAG patients were divided by outcome 1 year after surgery, lysyl oxidase-like 2 protein was significantly higher in both aqueous humor and Tenon's tissue of the failure group. The level of lysyl oxidase-like 2 protein was significantly correlated with that of TGF-β in the Tenon's tissue. Lysyl oxidase-like 2 level in the aqueous humor (r = 0.563, P < 0.001) and Tenon's tissue (r = 0.760, P < 0.001) had significantly negative correlation with bleb area. The TGF-β and lysyl oxidase-like 2 levels at the time of surgery were significantly correlated with 1-year outcomes of glaucoma surgery. The level of lysyl oxidase-like 2 was significantly correlated with that of TGF-β, suggesting induction by TGF-β. Modulation of lysyl oxidase-like 2 levels may have important applications in glaucoma surgery.

Correlation Between Filtering Bleb Morphology, Expression of Inflammatory Marker HLA-DR by Ocular Surface, and Outcome of Trabeculectomy

To correlate clinical bleb characteristics and the expression of human leukocyte antigen (HLA)-DR by conjunctiva with the outcome of trabeculectomy. In this cross-sectional study, bleb morphology was assessed at slit lamp using the Moorfields Bleb Grading System in 85 eyes of 85 patients. Conjunctival specimens were collected from superior conjunctiva by impression cytology and analyzed for the expression of HLA-DR on epithelial and antigen-presenting cells. The success of trabeculectomy was defined as intraocular pressure <21 mm Hg without antiglaucoma drops. Differences in bleb characteristics and expression of HLA-DR between eyes with surgical success and failure were examined. Fifty-eight of 85 eyes with successful trabeculectomy had significantly greater central and maximal area of the bleb (P<0.001) with decreased vascularity of the central (P=0.02) and peripheral part of the bleb (P=0.03). The expression of HLA-DR on conjunctival epithelial cells and antigen-presenting cells was not different between the eyes with successful and failed trabeculectomy and also not between the eyes with and without topical glaucoma medication or topical corticosteroid eye drops. Successful trabeculectomy was associated with greater area and decreased vascularity of the bleb but not with diminished expression of inflammatory marker by ocular surface. Presence of subclinical inflammation in eyes without eye drops may result from the transcellular aqueous pathway towards the ocular surface, especially in functioning blebs with adjunctive mitomycin C.

Prospective study of surgical outcomes and bleb morphology using indocyanine green as a surgical dye in trabeculectomy with mitomycin C

To investigate the effect of adding indocyanine green to mitomycin C in augmented trabeculectomy. A prospective, non-comparative interventional case series. A total of 37 eyes of 37 patients followed up for 1 year. A solution containing 12.5 mg/mL of indocyanine green was added to mitomycin C, resulting in an mitomycin C concentration of 0.2-0.4 mg/mL, which was applied to bare sclera and Tenon's capsule for 3 min during trabeculectomy. Visual acuity, intraocular pressure, bleb morphology, Moorfields Bleb Grading System scores and complications. Indocyanine green could be visualized on clinical examination for all eyes on the first postoperative day. Mean intraocular pressure decreased from 22.9 ± 6.2 mmHg to 12.1 ± 4.4 mmHg postoperatively (P < 0.001) at 1 year. Thirty-four eyes (91.9%) achieved an intraocular pressure of less than 21 mmHg at final visit without additional topical intraocular pressure-lowering medications. Three eyes (8.1%) developed bleb failure and required Baerveldt device implantation. There were no cases of blebitis or late bleb leak. No adverse effects attributable to indocyanine green could be identified postoperatively. The addition of indocyanine green during trabeculectomy improves the visibility of antimetabolites intraoperatively and allows for the estimation of antimetabolite treatment area intraoperatively and postoperatively. It appears to have no adverse effect on surgical outcomes and complication rates, while improving safety of antimetabolite use.

Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial

To verify the safety and efficacy of Ologen (OLO) implant as adjuvant compared with low-dosage mitomycin-C (MMC) in trabeculectomy. This was a prospective randomized clinical trial with a 24-month follow-up. Forty glaucoma patients (40 eyes) were assigned to trabeculectomy with MMC or OLO. Primary outcome includes target IOP at ≤21, ≤17, and ≤15 mm Hg; complete (target IOP without medications), and qualified success (target IOP regardless of medications). Secondary outcomes include bleb evaluation, according to Moorfields Bleb Grading System (MBGS); spectral domain optical coherence tomography (SD-OCT) examination; number of glaucoma medications; and frequency of postoperative adjunctive procedures and complications. The mean preoperative IOP was 26.5 (±5.2) in MMC and 27.3 (±6.0) in OLO eyes, without statistical significance. One-day postoperatively, the IOP dropped to 5.2 (±3.5) and 9.2 (±5.5) mm Hg, respectively (P=0.009). The IOP reduction was significant at end point in all groups (P=0.01), with a mean IOP of 16.0 (±2.9) and 16.5 (±2.1) mm Hg in MMC and OLO, respectively. The rates and Kaplan-Meier curves did not differ for both complete and qualified success at any target IOP. The bleb height in OLO group was higher than MMC one (P<0.05). SD-OCT analysis of successful/unsuccessful bleb in patients with or without complete success at IOP ≤17 mm Hg indicated a sensitivity of 83% and 73% and a specificity of 75% and 67%, respectively, for MMC and OLO groups. No adverse reaction to OLO was noted. Our results suggest that OLO implant could be a new, safe, and effective alternative to MMC, with similar long-term success rate.

ISRCTN12125882 - Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma - Study Protocol

BackgroundExcessive wound healing, with scarring of the episcleral tissue or encapsulation of the filtering bleb is the main reason for failure in trabeculectomy. Ranibizumab, an inhibitor of the Vascular Endothelial Growth Factor (VEGF), is seen as a promising candidate to prevent or treat extensive wound healing. We describe the design of a two phased study, i) assessing the local tolerability and safety of topical ranibizumab and ii) assessing the efficacy of topical ranibizumab against placebo in patients who underwent trabeculectomy with mitomycin C combined with phacoemulsification and intra ocular lens (IOL) implantation.Methods/DesignIn the first phase five patients that had trabeculectomy with mitomycin C combined with phacoemulsification and IOL implantation will be treated with topical ranibizumab (Lucentis®) eye drops (2 mg/ml) four times daily for one month. The treatment will be started at the first postoperative day. Patients will be assessed for local and systemic side effects using a standardised schedule. In the second phase, after successful completion of phase 1, consenting eligible patients who underwent trabeculectomy with mitomycin C combined with phacoemulsification and IOL implantation will be randomised to either receive topical ranibizumab eye drops (2 mg/ml) four times daily for 1 month or placebo (BSS 4x/d for 1 month). Patients will be reviewed weekly for 4 weeks until conjunctival sutures are removed. Further follow up examinations are planned after 3 and six months. Assessment of differences in the intraocular eye pressure will be considered primary, and bleb appearance/vascularisation using a standardized photography and the Moorfields bleb grading system, postoperative intraocular pressure and conjunctival wound healing problems will be considered secondary outcome parameters.DiscussionAnti-VEGF-antibodies might be more effective in preventing scaring and might have fewer toxic side effects than the currently used anti-metabolites and may replace them in the long term.Trial RegistrationISRCTN: ISRCTN12125882

Assessment of Bleb Morphologic Features and Postoperative Outcomes After Ex-PRESS Drainage Device Implantation Versus Trabeculectomy

To investigate bleb morphologic features and postoperative outcomes after Ex-PRESS drainage device (Alcon Laboratories) implantation versus trabeculectomy. Retrospective, consecutive case-control series. Information was collected from the charts of 35 consecutive Ex-PRESS procedures and 35 consecutive trabeculectomy procedures with at least 2 years of follow-up. Intraocular pressure (IOP), bleb morphologic features, reduction of dependence on medication, visual recovery, number of postoperative visits, and postoperative complication rates were compared between groups. Average follow-up was 28 months (standard deviation, 3.23 months). Mean IOP measurements were similar after 6 months, then became slightly higher in the Ex-PRESS group at 1 year and at the final follow-up (P = .004 and P = .008, respectively). Final percent IOP lowering was similar between groups (P = .209). Unqualified success was achieved in 77.14% of Ex-PRESS and 74.29% of trabeculectomy procedures at last follow-up (P = 1.00). An additional 5.71% and 8.57% reached qualified success for Ex-PRESS and trabeculectomy surgeries, respectively (P = .99). Evaluation by the Moorfields Bleb Grading System revealed less vascularity and height but more diffuse area associated with the Ex-PRESS blebs, although these differences were absent at study completion. There were fewer cases of early postoperative hypotony and hyphema and quicker visual recovery in the Ex-PRESS group. The Ex-PRESS group required fewer postoperative visits compared with the trabeculectomy group (P < .000). Success of Ex-PRESS surgery, as defined in our study, was similar to trabeculectomy. Final IOP measurements were slightly lower after trabeculectomy compared with Ex-PRESS. Differences in some postoperative outcomes faded with follow-up. There remains a need for long-term prospective studies comparing these 2 procedures.

Imaging of blebs after phacotrabeculectomy with Ologen collagen matrix implants

ObjectiveTo analyse blebs of phacotrabeculectomies performed with Ologen collagen implants (ProTop & MediKing, Taipei, Taiwan) and to compare these with blebs of mitomycin C (MMC)–augmented phacotrabeculectomies.Methods33 participants underwent phacotrabeculectomy with...

Bleb Morphology and Vascularity After Trabeculectomy With Intravitreal Ranibizumab: A Pilot Study

To investigate outcomes after trabeculectomy using intraoperative intravitreal ranibizumab and topical mitomycin C (MMC) vs MMC alone. Prospective randomized single-site pilot study. Patients diagnosed with primary open-angle glaucoma were randomized 1:1 to either combination intravitreal ranibizumab 0.5 mg and topically applied MMC (0.4 mg/mL for 2 min) or MMC (0.4 mg/mL for 2 min) therapy alone at time of trabeculectomy surgery. The primary endpoint measured was bleb morphology and vascularity using the Moorfields Bleb Grading System. Unqualified success was defined as postoperative intraocular pressure (IOP) of >5 and <22 mm Hg and a 30% decrease from baseline without use of postoperative hypotensive drops. Qualified success was defined as postoperative IOP of >5 and <22 mm Hg and a 30% decrease from baseline with use of postoperative hypotensive drops. Ten patients were randomized to either standard trabeculectomy with MMC (Group A) or trabeculectomy with intravitreal ranibizumab and MMC (Group B). All patients completed the study and were classified as unqualified successes. There were statistically significant differences in peripheral bleb area (P = .02), peripheral bleb vascularity (P = .02), and non-bleb-related peripheral conjunctiva vascularity (P = .0003), with Group B exhibiting more diffuse blebs with a lower degree of vascularity. Combination intravitreal ranibizumab and topical MMC at time of trabeculectomy resulted in more diffuse blebs with less vascularity when compared to use of topical MMC alone. Further studies are planned to better understand the utility of anti-vascular endothelial growth factor agents as modulators of wound healing post trabeculectomy.