Fuchs' Endothelial Corneal Dystrophy

Over the past decade, the management of Fuchs' endothelial corneal dystrophy (FECD) and pseudophakic bullous keratopathy (PBK) has been revolutionized by the development of posterior lamellar keratoplasty techniques: DSAEK and DMEK. DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) involves replacing the patient's endothelium and pathological descemetum with a descemetic endothelial graft combined with a thin stromal lamella. The endothelial density of the grafts is generally greater than 2,400 cells/mm². Depending on the grafting center and tissue bank, grafts may be either pre-cut in the tissue bank or cut on the operating table by the surgeon himself. The donor graft is placed on an artificial anterior chamber, and automated microkeratome cutting produces grafts with an average thickness of 100 to 200µm, sometimes less than 100um (known as UT-DSAEK or ultra-thin DSAEK). DMEK (Descemet Membrane Endothelial Keratoplasty) is a strictly endothelium and Descemet's membrane graft, as close as possible to the original anatomy of the cornea. The graft is dissected manually either in a tissue bank (pre-cut grafts) or on the operating table by the surgeon. The thickness of the graft is between 15 and 18 microns. The primary objective of this observational cohort is to compare the evolution of visual acuity after DMEK, DSAEK or UT-DSAEK transplantation. Secondary objectives are to compare the evolution of endothelial cell density, corneal thickness and early and late post-operative complications, and to identify factors predictive of these different endpoints.

Fuchs endothelial corneal dystrophy (FECD) is the leading indication for corneal transplantation worldwide. It is characterized by the accumulation of guttae and progressive loss of corneal endothelial cells, leading to corneal edema and visual impairment. Endothelial keratoplasty remains the standard treatment; however, graft shortages have driven the development of cell-based therapies involving the injection of cultured endothelial cells. A key unresolved issue is whether removal of the pathological endothelium prior to injection improves cell adhesion. Clinical data are limited and sometimes contradictory, particularly regarding endothelial polishing. The actual effectiveness of this procedure in removing guttae and enhancing the survival of injected cells remains uncertain. Therefore, an in vivo clinical evaluation is required to assess its impact on guttae removal.

Study Overview This study aims to evaluate the visual outcomes, quality of vision, and patient satisfaction after receiving an extended range PRoF intraocular lens (IOL) during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This surgery is typically performed to treat patients with both corneal endothelial dysfunction and cataracts. By testing a newer IOL, the PureSee™ extended PRoF IOL, this study hopes to improve the way ophthalmologists plan surgeries and select IOLs for these patients, ultimately helping surgeons optimize the results and expand the options available for people undergoing this procedure. Purpose of the Study The goal of this study is to evaluate how well the PureSee™ IOL works in terms of intermediate visual acuity (how well participants can see things at an arm's length). The investigators will also measure the quality of vision, satisfaction, and whether participants need glasses after surgery. The investigators have set the following goals for this study: Primary Goal: To measure how well patients can see intermediate distances (uncorrected intermediate visual acuity, or UIVA) after receiving the PureSee™ IOL during triple DMEK surgery. Secondary Goals: To understand how independent patients are from glasses after surgery. To measure patients' uncorrected and best-corrected visual acuity (sharpness of vision) at distance, intermediate, and near vision after surgery. To evaluate the uncorrected defocus curve (how the vision of participants changes when focusing at different distances). To measure contrast sensitivity (how well participants can see in low-light conditions or with subtle contrasts). Who Can Join This Study? To participate in this study, participants need to: Be undergoing triple DMEK surgery for endothelial dysfunction and cataract at the time of enrollment. Be eligible to receive an extended range of vision IOL as part of the procedure. This study is looking for patients who are interested in understanding how new IOL technology might improve their postoperative vision quality and reduce their dependence on glasses. What Will Happen During the Study? Participants will have their visual outcomes and satisfaction measured at specific times following surgery. This includes: Testing uncorrected and best-corrected visual acuity at several distances (distance, intermediate, and near). Completing a survey about how satisfied they are with their vision and how often they need glasses or contact lenses. Undergoing testing to measure contrast sensitivity (how well participants can see in low-light conditions). Why Is This Study Important? The results of this study will help doctors make better decisions about which IOLs to use during triple DMEK surgery. By evaluating the PureSee™ extended PRoF IOL, the investigators hope to expand options for patients and potentially improve visual outcomes and postoperative satisfaction. Ultimately, this study could help improve the quality of life for patients who have both cataracts and endothelial dysfunction. Study Duration Participants can expect to undergo their last assessment 6 months post-surgery to track their progress.

The goal of this clinical trial is to learn if a longer period of lying on the back after corneal transplant surgery (Descemet Membrane Endothelial Keratoplasty, DMEK) helps the transplant stick better in the eye. It will also learn about side effects, such as back pain. The main questions it aims to answer are: * Does lying on the back for 5 days reduce the size of transplant detachment compared to lying on the back for only 1 day? * Do participants who lie on their back longer need fewer additional procedures (rebubbling)? * What symptoms or problems do participants experience with short vs. long back positioning? Researchers will compare two groups: * 1 day of back positioning * 5 days of back positioning Participants will: * Be randomly assigned to one of the two positioning groups * Wear a movement sensor that records head position * Have their eyes checked regularly with vision tests and imaging (AS-OCT) * Answer questions about their vision and comfort * Keep a diary of any positioning-related complaints, such as back pain

The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.

This prospective multicenter diagnostic study aims to externally validate and extend the SUCCESS Score for predicting the need for endothelial keratoplasty after cataract surgery in patients with Fuchs endothelial corneal dystrophy (FECD). The model's performance and clinical utility are assessed using discrimination, calibration, and reclassification metrics.

This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.

The goal of this observational study is to compare the mid- to long-term efficacy of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) in patients with moderate to severe Fuchs' endothelial corneal dystrophy (FECD) complicated by cataracts. The main questions it aims to answer are: Does FLACS lead to better preservation of corneal endothelial cells compared to CPS in patients with moderate to severe FECD? How do visual outcomes and corneal transparency compare between FLACS and CPS in this patient population? Comparison Group: Researchers will compare patients undergoing FLACS with those undergoing CPS to evaluate differences in endothelial cell loss, corneal thickness, visual acuity, and corneal transparency. Participants: Adults aged 40 years and older diagnosed with moderate to severe FECD (endothelial cell density \<1500 cells/mm²). Patients scheduled for cataract surgery at participating centers. Participants will undergo: Preoperative evaluations, including visual acuity tests, corneal endothelial cell density assessment (central and five peripheral zones), corneal thickness, and corneal densitometry. Surgical intervention with either FLACS or CPS. Postoperative follow-ups at 1 day, 3 days, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years, including assessments of endothelial cell density, visual acuity, and corneal thickness. This study aims to provide evidence-based recommendations for optimizing surgical strategies in high-risk patients with FECD and cataracts.