Partial Range Of Field IOLs in DMEK-Enabled Procedures

Summary

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.

Conditions

• Cataract
• Fuchs Endothelial Corneal Dystrophy

Interventions

DEVICE

combined cataract and lamellar endothelial keratoplasty

PureSee™ IOL in combined cataract and lamellar endothelial keratoplasty

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  lead OTHER

Principal Investigators

• Karolien Termote, MF, Febo · Universitair Ziekenhuis Brussel

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2028-02-29

Completion

2028-02-29

Countries

• Belgium

Study Locations