Prospective Clinical Pilot Study Research Articles

PWE-271 Ratio of IL 10 over IL 12 is a novel surrogate to evaluate the severity of non-alcoholic steatohapatitis (NASH)—a prospective clinical pilot study

IntroductionNon-alcoholic steatohepatitis (NASH) is a growing global epidemic progressing to cirrhosis, liver failure, HCC, warrants liver transplant. The natural history is still not well defined, inflammatory cytokines, intrahepatic immune traffic,...

PWE-269 Heat shock protein-70 (hsp-70) a novel surrogate marker for hypoxia induced liver injury (HILI)—a prospective open level control clinical pilot study

IntroductionHypoxic hepatopathy (HH) is a common entity in hospital with impaired hepatic perfusion secondary to transient altered cardio pulmonary haemodynamics, manifesting with sharp rise of transaminases with perfusion injury rarely...

A prospective randomised clinical pilot study to compare the effectiveness of Biobrane® synthetic wound dressing, with or without autologous cell suspension, to the local standard treatment regimen in paediatric scald injuries

BackgroundScald is the most common cause of burn in children in Australia. The time taken by the burn wound to heal impacts on scar outcome. Commonly scald injuries are treated conservatively; in our unit the practice is that if healing does not occur within 10 days, surgery is used to aid healing with the aim of improving scar outcome. This randomised controlled pilot study compares early treatment regimens to facilitate tissue salvage and reduce the incidence of definitive surgery at 10 days following scald injury. MethodsAll paediatric patients with partial thickness scald injury were clinically assessed between July 1, 2009 and June 30, 2010. A burn of 2% TBSAB or more and deemed not to heal within 10 days, were considered for the trial. These patients were randomised to one of three treatment arms: the local standard treatment (Intrasite™, Acticoat™ and Duoderm® dressings every 2–3 days) with surgery at 10 days, Biobrane® only or Biobrane® and autologous cell suspension using the ReCell® kit. The primary outcome was surgery performed after 10 days; secondary outcomes were rates of healing, pain experienced, and scar outcomes. Results15% of scald presentations in the 12 month period met the eligibility criteria. 13 patients were recruited into the pilot study; early intervention was associated with a decreased time to healing with fewer dressing changes, less pain and better scar outcomes. ConclusionInvestment of surgical resources in the acute stages within 4 days of injury saved on nursing time, dressing, analgesic and scar management costs.

Pilot study of unidirectional E-glass fibre-reinforced composite resin splints: Up to 4.5-year clinical follow-up

ObjectivesThis prospective clinical pilot study evaluated the performance of fibre-reinforced-composite resin (FRC) splints on mandibular anterior teeth. MethodsBetween June-2003 and January-2008, 19 patients (7 females, 12 males, 45–72 years old) from a group of consecutive patients who completed periodontal therapy received E-glass FRC splints (everStick Perio, StickTech) in combination with two types of flowable and restorative resin-composites (Filtek Flow, Filtek Supreme, n=11; Tetric Flow, Tetric-Ceram, n=8). Only patients with vital teeth, presenting mobility of grade 3, having at least one canine with no mobility on both sides of the dental arch were assigned for a splint therapy. The patients were recalled for periodical follow-up controls first at 6 months and thereafter annually. The evaluation protocol involved technical failures [chipping, debonding or fracture (tooth/restoration)] and biological failures (caries)]. Periodontal pocket depth (PPD) and clinical attachment level (CAL) were measured 6 months after splinting and annually. Six sites were measured for each natural tooth at the mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual sites. ResultsAll splints were applied from canine to canine in the mandible. In total, 5 recalls were performed and no drop-out was experienced. One partial debonding of the FRC splint with Tetric Flow/Tetric-Ceram combination was observed after 40 months. No caries was found around any of the splints and no teeth had to be extracted until the final follow up. The splinted teeth were found to be vital in the vitality tests. Overall survival rate was 94.8% (Kaplan–Meier). The survival rate was not significantly affected by the composite type (Filtek-Flow/Filtek Supreme: 100%, Tetric Flow/Tetric Ceram: 96% (p=0.92) [Kaplan–Meier, Log Rank (Mantel–Cox) (CI=95%)]. Hazard ratio for Tetric Flow/Tetric Ceram group was 0.05 (95% CI) and for Filtek Flow/Filtek Supreme group 0.00 (95% CI). Whilst overall PPD measurements of the dentition ranged between 6 and 12mm, the CAL measurements ranged between 4.9 and 10mm at baseline. The mean PPD for the splinted teeth decreased from 8.9±1.8mm to 5.2±1.2mm, and CAL decreased from 7.2±1.6mm to 4.6±1mm at the end point. ConclusionDirect tooth splinting with E-glass FRC material performed successfully up to 4.5 years. Periodontal status of the splinted teeth showed decreased PPD and CAL.

Nutritional status in intensive care unit patients: a prospective clinical cohort pilot study

Nutritional status in intensive care unit patients: a prospective clinical cohort pilot study

Nutritional status in intensive care unit patients: a prospective clinical cohort pilot study

Previous researches have shown that the nutritional status of patients in the intensive care unit (ICU) was poor on admission and appears to decline during their stay in the ICU. Critically ill patients are prone to malnutrition because their hypermetabolic disorders lead to an increase in nutritional requirements that are not often met with the nutrition supplied. The aim of this study was to assess the nutritional status and hs-CRP of ICU patients on admission and discharge from the hospital. Twenty-nine neurological ICU patients (20–87 years old) underwent fasting blood sample collections, anthropometric measurements and impedance analysis on admission and discharge at Ghaem Teaching Hospital. NRS 2002 was used to determine malnutrition in ICU patients. Markers of nutritional status changed from admission into the ICU until discharge as follows: weight, BMI and triceps skinfold thickness decreased (p < 0.001, p < 0.001 and p < 0.005, respectively). hs-CRP was decreased over the stay in the hospital (admission = 19.4 ± 16.3, discharge = 13.8 ± 14.5, p value = 0.11). The percent of patients at risk of malnutrition decreased during stay in ICU (not significant). Prevalence of malnutrition was as high as 47.6% on admission. The nutritional status of patients was slightly improved over the period of their stay in hospital using NRS 2002 method.

Surgery-First Accelerated Orthognathic Surgery: Postoperative Rapid Orthodontic Tooth Movement

Clinically, we have observed the phenomenon of postoperatively accelerated orthodontic tooth movement in patients who had orthognathic surgery. This phenomenon lasts for a period of 3 to 4 months. However, the underlying mechanisms of this phenomenon have not been well studied yet. The purpose of this prospective clinical pilot study was to study the postoperative changes in bone physiology and metabolism and the corresponding responses in the dentoalveolus, such as the changes in tooth mobility. Twenty-two consecutive adult patients who had 2-jaw orthognathic surgery were included in this study. The levels of serum alkaline phosphatase and C-terminal telopeptide of type I collagen (ICTP), as well as the tooth mobility of the maxillary and mandibular incisors based on the Periotest method (Siemens AG, Bensheim, Germany), were examined preoperatively and 1 week, 1 month, 2 months, 3 months, and 4 months postoperatively. The data were analyzed statistically. Both tooth mobility of the maxillary and mandibular incisors and ICTP significantly increased from 1 week to 3 months postoperatively and then decreased to their preoperative levels in the fourth month postoperatively. The changes in tooth mobility were significantly in correspondence with the changes in ICTP. The alkaline phosphatase level significantly increased from the first to fourth month postoperatively, but it was not significantly correlated to the changes in tooth mobility. The orthognathic surgery triggers a 3- to 4-month period of higher osteoclastic activities and metabolic changes in the dentoalveolus postoperatively, which possibly accelerates postoperative orthodontic tooth movement.

Clinical evaluation of posterior all-ceramic FPDs (Cercon): A prospective clinical pilot study

This study prospectively evaluated the clinical performance of posterior zirconium-oxide-based all-ceramic fixed partial dentures (FPDs). Forty-two abutments of 21 Cercon FPDs were fitted in 20 patients at the Tsurumi University Dental Hospital from August 2005 to August 2006. The performance of these FPDs was evaluated using the California Dental Association (CDA) quality assessment system at baseline and at all follow-up examinations. All FPDs were examined after a mean observation period of 28.1 (+/-3.4) months. During the observation period, no fracturing of FPDs was seen. All of the FPDs examined were rated as satisfactory with regard to all factors at the follow-up examinations based on the CDA quality assessment criteria. Within the limitations of this short-term clinical study, no core framework fractures were seen. According to the CDA criteria, 100% of the FPDs were rated as satisfactory during this observation period.

An external neck brace to support the peristomal fixation of an automatic stoma valve (ASV): 3D stereophotogrammetrical assessment

Conclusion: The external neck brace (ENB) is a new concept in the improvement of peristomal fixation of an automatic stoma valve (ASV), which was evaluated with a new imaging method. The addition of the ENB to the Flexiderm (FLD) and Xtrabase (XB) adhesives significantly reduced absolute mean differences between the speech and the non-speech conditions. Objectives: After total laryngectomy, peristomal fixation problems of adhesives and stoma valves are still the main reasons for the relatively small number of patients that actually use an ASV on a daily basis. Several concepts could not prevent these fixation problems. To overcome or at least diminish these attachment problems, an ENB has been developed to support peristomal adhesives. The mechanism behind this brace is that it absorbs the high stomal pressures created during tracheoesophageal speech. In this pilot study the mechanism outlined above was objectified using 3D stereophotogrammetrical measurements. Methods: This was a prospective clinical pilot study in a university hospital setting, involving nine laryngectomized patients. Ten 3D images were taken of all patients using stereophotogrammetry; five pictures during a moment of speech and five during a non-speech condition. Two different peristomal adhesives were used during these two conditions: the Provox® Flexiderm™ (FLD) adhesive and the Provox® Xtrabase® (XB) adhesive, both with and without the addition of the ENB. Besides these four combinations, a final fifth set-up using all the components (FLD + XB-ring + ENB) was added. Absolute mean differences were compared between two photographs of the area of interest, which is covered by the adhesive for all five different set-ups mentioned above. This was done during speech and non-speech conditions. Results: Absolute mean differences at the region of the base plate between speech and non-speech conditions were most obvious while using just the FLD adhesive (4.70 mm). The use of the ENB significantly reduced the absolute mean difference to 0.58 mm (p < 0.02). The suggested set-up with a basis of the FLD adhesive combined with the solid ring extracted from the XB adhesive and the ENB showed the smallest absolute mean difference of 0.38 mm between speech and non-speech conditions (p < 0.025).

Effect of root coverage on oral health impact profile (g49): a pilot study.

Purpose. The aim of this prospective longitudinal clinical pilot study was the evaluation of the effect on the Oral Health Impact Profile (OHIP) and patient-centered results of the envelope technique for Connective Tissue Graft (CTG). Methods. Sixteen patients (11 females) 24 to 71 years of age (42.6 ± 11.1) received CTG that had been harvested from the palate and grafted using the envelope technique. Prior to and 3 months after surgery, all patients were examined clinically, completed the OHIP-G49 questionnaire, and were asked to judge the results of surgery. Results. Mean baseline recession depth of 2.5 ± 0.8 mm was reduced by 1.2 ± 0.9 mm (P < .001). Root coverage amounted to 48 ± 39%. In 5 of 16 defects complete root coverage was achieved. Pain at the donor site was more pronounced than at recipient site regarding prevalence (8/6; P = .007), intensity (2.1 ± 2.3/1.1 ± 1.9 [visual analogue scale]; P = .016), and duration (1.4 ± 2.3/0.8 ± 1.4 days; P = .042). Baseline OHIP (15.7 ± 12.1) was decreased by 3.6 ± 8.5 three months after surgery (P = .139). Thirteen patients (81%) would undergo CTG surgery for similar reasons again. Conclusions. Root coverage using CTG according to the envelope technique provided improvement of OHIP as early as 3 months after surgery. Over all, patients were reasonably satisfied with the surgical technique and its results.

Treatment of children with amblyopia by perceptual learning

Recent studies have shown that perceptual learning has the potential to treat amblyopia. In this study we tested whether a recent perceptual learning technique that improved visual functions in adults can be applied to improve the vision of children after the conventional treatment of patching has failed. A prospective clinical pilot study was carried out in children who were non-compliant with patching or in whom patching had failed despite good compliance. Each child underwent a complete eye examination before and after treatment. The treatment was based on a perceptual learning technique that was similar to the adult study [Polat, U., Ma-Naim, T., Belkin, M., & Sagi, D. (2004). Improving vision in adult amblyopia by perceptual learning. Proceedings of the National Academy of Sciences of the United States of America, 101(17), 6692–6697]. Between blocks, children played a computer game to engage and maintain their attention in order to increase compliance. Each child received two treatment sessions a week, with a total of not more than 40 sessions. Each session lasted for about 1 h and included a total practice time of about 30 min. The age of the children ( n = 5) was between 7 and 8 years (mean 7.3 years). For the whole group, the average improvement in visual acuity was 1.5 Snellen lines or 2.12 ETDRS lines. The training improved the contrast sensitivity, which reached the normal range after treatment. Thus, the perceptual learning technique can be successfully used to treat children with amblyopia even after the conventional treatment of patching fails.

The use of dynamic CT surview for cervical spine clearance in comatose trauma patients: A pilot prospective study

Bedside flexion and extension fluoroscopy was proposed for detecting occult ligamentous instability in comatose trauma patients. Nevertheless, a recent study showed that the C7-T1 motion segment is rarely visualised by this technique. We propose a new method for clearing the cervical spine in comatose patients. We conducted a prospective clinical pilot study on 31 consecutive comatose trauma patients to evaluate a new dynamic imaging technique for cervical spine clearance in comatose trauma patients. All patients were examined by a fine-cut helical CT scan of the entire cervical spine (C-spine) and by four-stage flexion-extension examination using the surview function of the CT scanner. The mean range of motion between extension and full flexion, the lowest visualised vertebrae, complications, positive findings, and the time from arrival to clearance was recorded. The mean range of motion of the subaxial cervical spine was 39 degrees . The C7-T1 segment was fully visualised at the CT surview in 15 patients. The C6-C7 segment was visualised in all patients. No complication directly related to the study protocol was observed. C-spine clearance was completed in less than 6h from arrival in 26 patients. The CT surview allows better visualisation of the C6-C7 and cervicothoracic junctions during flexion and extension. A short series of CT cuts can be used when visualisation is inadequate. Further studies are needed to assess the risks and benefits of the suggested protocol.

Minilaparotomy Cholecystectomy as a Day Surgery Procedure: A Prospective Clinical Pilot Study

In some studies minilaparotomy cholecystectomy (MC) has been shown to be as good as laparoscopic cholecystectomy (LC) in the surgical treatment of cholecystolithiasis. To our knowledge, the MC operation is rarely considered as a day surgery procedure. Thirty elective symptomatic non-complicated patients were included in the study during the end of the year 2004 to June 2005. The mean age of patients was 52 years (range 27-68), the mean body mass index 29 kg/m2 (range 19-41). Gallstones were confirmed with ultrasound and the preoperative liver laboratory tests were normal in all patients. A five (+/-2) centimetre-long incision was used avoiding to split the rectus abdominis muscle. All patients were re-evaluated four weeks postoperatively with the follow-up letter. The average operating time was 51 minutes (range 30-105 minutes). Day surgery was possible in 25 cases (83%). Five patients (17%) stayed over night at the hospital. There were four (13%) conversions to conventional cholecystectomy. The average postoperative sick leave was 16 days (range 14-30). Two patients returned to hospital. One patient had wound pain, but no complication was found, and the patient was not admitted. One patient had a wound infection and spent 6 days in the hospital. Twenty-nine (97%) patients were satisfied with the operation and were ready to recommend it for other patients. The results of this study support the suitability of MC as a day surgery procedure, but a prospective randomised trial is needed to evaluate the relative advantages of MC and LC.

High anticipatory stress plasma cortisol levels and sensitivity to glucocorticoids predict severity of coronary artery disease in subjects undergoing coronary angiography

Hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis and/or increased sensitivity of peripheral tissues to glucocorticoids may be associated with the dysmetabolic syndrome and its cardiovascular sequelae. In this prospective pilot clinical study, we examined possible associations between HPA axis activity and severity of cardiovascular disease. We measured morning serum cortisol and intima media thickness (IMT) of carotid and femoral arteries in 105 subjects before undergoing coronary angiography for suspected coronary artery disease (CAD). In a randomly selected 46 of these subjects, we obtained late afternoon and morning cortisol levels (after ultralow-dose dexamethasone [0.25 mg] treatment) and determined their genotype for the Bcl1 polymorphism of the glucocorticoid receptor gene, which has been associated with increased sensitivity to glucocorticoids. There was significant association between morning preangiography cortisol levels and the number of vessels with severe stenosis in the angiography, independently of age or sex ( P = .002), and a trend for a positive correlation between morning cortisol and the IMT of the femoral artery ( P = .057). Bcl1 G allele homozygotes had a significantly higher carotid IMT ( P = .005) and a nonsignificant tendency for higher waist-hip ratio ( P = .059). Hyperactivity of the HPA axis in anticipation of a stressful procedure, such as angiography, may be an index of CAD severity. Chronic HPA axis hyperreactivity combined with tissue hypersensitivity to glucocorticoids may contribute to more severe atherosclerosis and CAD.

The efficacy of posterior three-unit zirconium-oxide–based ceramic fixed partial dental prostheses: A prospective clinical pilot study

Although zirconium-oxide-based restorations for fixed partial denture prostheses (FPDPs) are available for use, clinical studies evaluating their longevity and related complications have not been published. The aim of this pilot clinical study was to assess the efficacy of zirconia-based posterior 3-unit FPDPs. Twenty 3-unit posterior FPDPs (Lava) were placed in 16 subjects who were missing a second premolar or a first molar, met specific inclusion and exclusion criteria, and provided informed consent. All teeth were prepared in a standardized manner: occlusal reduction of 1.5 to 2 mm; axial reduction of 1 to 1.5 mm; a 1.0-mm, 360-degree rounded shoulder placed 0.5 mm subgingivally on the facial aspect and supragingivally on the lingual aspect on sound tooth structure; and rounded internal line angles. Impressions were made with vinyl polysiloxane (Express) impression material. Frameworks were fabricated using a computer-aided design/computer-assisted manufacturing technique with a retainer thickness of 0.6 mm, and a minimal connector surface area of 9 mm(2). Restorations were luted with resin-modified glass-ionomer cement (Rely X luting). Recall appointments were made after 2 weeks and 6, 12, 18, 24, and 36 months. Clinical fracture resistance, marginal discoloration, marginal adaptation, radiographic proximal recurrent decay, and periapical pathoses were assessed over time using modified Ryge criteria. The probability distributions of these variables were calculated for the baseline data as well as for recall data. Mean follow-up was 31.2 months. Fifteen restorations were rated Alpha in all measured parameters. Minor chipping of veneering porcelain was detected in 5 restorations rated Bravo for clinical fracture resistance and Alpha for all other assessed parameters. One restoration was rated Bravo in terms of marginal integrity at 36 months. Zirconia-based posterior 3-unit FPDPs performed well after short-term service.

A pilot study evaluating the safety and effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection

Changes in the indigenous vaginal microflora with uropathogenic bacteria can predispose women to frequently recurring bacterial cystitis. Lactobacilli used as probiotics have played an important role in preventing the colonization of pathogenic bacteria in the vagina. A prospective clinical pilot study was performed to confirm the safety and effectiveness of Lactobacillus vaginal suppositories against the recurrence of bacterial urinary tract infection (UTI). The patients enrolled in the study were instructed to administer vaginal suppositories containing the strain Lactobacillus crispatus GAI 98322. A significant reduction in the number of recurrences was noted, without any adverse complication ( P = 0.0007). The administration of vaginal suppositories containing L. crispatus GAI 98332 seemed to be a safe and promising treatment for the prevention of recurrent UTI.

Evaluation of a new condensed extra-corporeal circuit for cardiac surgery: a prospective randomized clinical pilot study

This prospective randomized clinical pilot study was conducted to evaluate a recently introduced reduced volume CPB system that is coated with the biopassive Xcoating. Twenty-two patients undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB), either with a fully heparin-coated CPB circuit (control, n=11) or with an Xcoating coated condensed extra-corporeal circuit (CondECC, n=11), were included. We examined activation of the complement system (C3bc and C4bc), activation of neutrophils (BPI), the acute phase response (interleukin (IL)-6, and acute phase proteins (LBP, AGP, and CRP)), myocardial tissue injury (troponin T), hemolysis (free hemoglobin (FHb)), and clinical outcome parameters. Preoperative risk profiles were identical for both patient groups. All patients went through the procedure without major complications and were discharged from the hospital. FHb and BPI levels at the end of pump support (p < 0.01) and at 15 min after the administration of protamine (p < 0.05) were significantly higher in the control group. In addition, FHb levels were still significantly elevated upon arrival on the cardiothoracic intensive care unit (CICU) in the control group (p < 0.05). C3bc and C4bc, acute phase proteins, IL-6, and troponin T concentrations, and clinical outcome variables were identical in both patient groups. In conclusion, the evaluated condensed extracorporeal circuit is a flexible and multifunctional CPB sytem that offers safe procedures. Furthermore, the results indicate improved biocompatibility of this option for extracorporeal circulation.

Molecular markers in the evaluation of autologous chondrocyte implantation

Purpose: With the help of molecular markers, it has become possible to quantify cartilage repair and degradation in joints. In this study, we attempt to determine whether or not molecular markers in synovial fluid can be helpful in defining the repair process following autologous chondrocyte implantation (ACI). Type of Study: As part of a prospective clinical pilot study, 17 patients were evaluated before, as well as 6 weeks, 3, 6, and 12 months after the ACI. A synovial analysis was performed and molecular markers for bone and cartilage metabolism were determined. Methods: A number of parameters, including pyridinium crosslink (PY), deoxypyridinolin (DPD), n-telopeptide (NTX) from type I collagen, MMP-1, MMP-3; TIMP-1, PICP, proteoglycan, and YKL-40 were analyzed. The levels were referenced to the total protein concentration of the synovial fluid. The synovial analyses were compared with clinical parameters (Larson score) and magnetic resonance imaging (MRI) examinations. Results: The analysis of the data revealed differing trends for the various synovial markers over time. The most remarkable marker was found to be DPD, which increased continuously between surgery and week 12, only to disappear after the repair process had ceased 1 year after surgery. All molecular markers for cartilage degradation increased initially after surgery and dropped off below the original levels 3 to 6 months later. Conclusions: The evaluation revealed that the determination of marker levels can provide valuable information regarding the metabolism of bone and cartilage in a joint. They seem to provide a method for monitoring the repair process associated with the various treatment forms for chondral lesions.Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 19, No 4 (April), 2003: pp 397–403

Relationship between bleeding time test and postextraction bleeding in a healthy control population.

We sought to determine whether cutaneous bleeding time (BT) is related to bleeding outcome measures after a single tooth extraction. This was a prospective clinical pilot study of 30 subjects. Cutaneous BT was evaluated before a single tooth extraction. After extraction, an oral BT was determined. Subjects were contacted 3 to 7 hours and 2 days after extraction to assess further postoperative bleeding. The mean cutaneous BT was 5.9 minutes (range 1.5-10.0 minutes). The mean oral BT was 7.5 minutes (range 0-20 minutes). Cutaneous BT did not correlate with oral BT or any of our measures of postoperative bleeding. However, the oral BT correlated with the number of hours of bleeding after surgery (R(s) = 0.54, P =.03). The time necessary to perform the extraction correlated with the extraction site bleeding 3 to 7 hours after surgery (R(s) = 0.67, P =.0006). Cutaneous BT did not correlate with measures of postoperative bleeding in the present study, but oral BT immediately after extraction correlated with the duration of subsequent postoperative bleeding.

Autologous serum for otherwise therapy resistant corneal epithelial defects - Prospective report on the first 70 eyes

The purpose of this prospective clinical pilot study was to evaluate the efficiency, practicability and safety of topical autologous serum for therapy resistant corneal epithelial defects. Between November 1999 and June 2001 autologous serum therapy was applied in 70 eyes of 67 consecutive patients (age 18 to 92 [average 59 +/- 18] years) with corneal epithelial defects refractory to standard clinical treatment at the Department of Ophthalmology University Erlangen-Nürnberg. We evaluated localization, size of the defect, time until epithelial wound closure and the incidence of recurrences in relation to the clinical diagnosis. The blood was obtained by venipuncture, centrifuged and the non-diluted serum was filled in sterile bottles, kept in the + 4 (o)C refrigerator and hourly applied during daytime. Simultaneous systemic and topical medication depended on the underlying disease. In 45 eyes corneal epithelial defects appeared after penetrating keratoplasty but in 25 eyes corneal epithelial defects were not related to a corneal transplant. The epithelial defect had a medium length of 4.2 +/- 2.4 mm and a width of 3.0 +/- 1.8 mm. Previously, the patients had been treated with maximal topical therapy (including hyaluronic acid) for 13 +/- 11 days. Treatment with autologous serum lasted from 4 to 45 (mean 16 +/- 11) days. A complete corneal re-epithelialization was achieved in 57 of 70 eyes (81 %) after 3 to 45 (mean 15 +/- 12) days. Forty-eight of these 57 eyes (84 %) had no recurrence during a follow-up of 12 +/- 4 months. In 9 eyes (16 %) a recurrent epithelial defect occurred one or two months after initial closure. These eyes were treated successfully with a second autologous serum therapy (6 x), amniotic membrane transplantation (2 x) or repeat keratoplasty (1 x). Thirteen eyes (19 %) without primary success of autologous serum applied for 11 to 50 days were finally treated successfully with amniotic membrane transplantation (10 x) or repeat keratoplasty (3 x). In persistent corneal epithelium defects, autologous serum therapy can be considered as an effective and practicable therapy without adverse reactions. Especially in eyes after complicated penetrating keratoplasty the prognosis may be improved and more invasive treatment modalities such as botulinum toxin injection, amniotic membrane transplantation or (repeat) penetrating keratoplasty may be avoided. Definitive determinants for the success of this novel therapy have not been identified, yet. However, eyes with accompanying deep stromal defects do not seem to be good candidates.