Abstract

This paper shows how a public eye and research hospital in Turkey initiated Six Sigma principles to reduce the number of complications occurring after penetrating keratoplasty surgeries. Data were collected for nine years. To analyse the complications among 55 patients (59 eyes) underwent penetrative keratoplasty, main tools of Six Sigma’s Define-Measure-Analyze-Improve-Control (DMAIC) improvement cycle such as SIPOC table and Failure, Mode and Effect Analysis (FMEA) were implemented. Sources and root causes of eleven types of complications were identified and reported. For a successful penetrating keratoplasty surgery patient’s anatomy, suitability of donor cornea, experience of ophthalmic surgeon, sterilization and hygiene, and performance of the equipment were determined to be the “critical-to-quality” factors. The complication with the highest hazard score was found to be the glaucoma. The process sigma level of the process was measured to be 3.1418. The surgical team concluded that all types of post-operative complications should be significantly reduced by taking the necessary preventive measures.

Highlights

  • Corneal eye disease is the fourth most common cause of blindness after cataracts, glaucoma and age-related macular degeneration, affecting more than 10,000,000 people worldwide

  • Penetrating Keratoplasty (PKP) is a standard full thickness transplant that involves the surgical removal of the central two-thirds of the damaged cornea

  • The analysis revealed that Types I, II and III were the three most frequently occurring complications in the PKP surgeries

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Summary

Introduction

Corneal eye disease is the fourth most common cause of blindness after cataracts, glaucoma and age-related macular degeneration, affecting more than 10,000,000 people worldwide. The surgical procedure restores vision and relieves pain and suffering caused by injured and diseased cornea with high success rate, studies continue to show many post-operative complications such as wound leaks, malpositioning of the donor cornea, suture exposure and infections, infiltration of immune due to suture, persistent epithelial defect, filamentary keratitis, primary endothelial insufficiency, glaucoma, cataract, acute choroidal detachment, epithelial down growth, fix dilated pupils, refractive changes, graft infections, recurrent disease, shallow anterior chamber, graft rejection, hypotony, cystoid macular edema, endophtalmitis and sympathetic ophthalmia [1] [4]-[11]. Residual astigmatism after PKP surgery may limit postoperative visual function and be the cause of decreased patient satisfaction in the presence of a clear graft [12]. When these complications occur, proper and prompt management is essential. Preventative measures will result in earlier visual rehabilitation and greater long-term graft survival

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