Partial Range Of Field IOLs in DMEK-Enabled Procedures

NCT07441616 | Not Yet Recruiting

• 1 other identifier: 25343_Profide
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dmek; triple; endothelial keratoplasty; fuchs; cataract; edof iol; partial range of field iol

Outcome Measures

Primary Outcomes (1)

• Uncorrected intermediate visual acuity on Radner reading chart in LogMAR (logarithm of minimum angle of resolution) scale (range -0.3 till 3),

  To evaluate the uncorrected intermediate visual acuity (UIVA) achieved through PureSee™ IOL (extended PRoF IOL) implantation in triple DMEK surgery at 66cm on Radner reading chart in photopic conditions and 100% contrast measured in LogMAR scale (range -0.3 till 3). Lower score indicates better outcome.

  From enrollment to 6 months post surgery

Secondary Outcomes (3)

• Patient reported spectacle independence measured with PRSIQ questionaire (patient reported spectacle independence questionaire) and PRVSQ (patient reported visual symptom questionaire) both in Likert scale with component scores from 1 till 6

  From enrollment till 6 months post surgery

• monocular uncorrected and best corrected distance, intermediate and near visual acuity as well as the uncorrected defocus curve in photopic conditions and 100% contrast measured in LogMAR scale (range -0.3 till 3) at 4m, 66cm and 40cm on EDTRS and Radner

  From enrollment till 6 months post surgery

• contrast sensitivity in photopic conditions without glare and mesopic conditions with and without glare with Clinical CSF V.2.0.1, (QVision Academy, Spain) in log10 units, Modulation tranfer function cut-off

  From enrollment till 6 months post surgery

Study Arms (1)

Single arm

EXPERIMENTAL

Device: combined cataract and lamellar endothelial keratoplasty

Interventions

combined cataract and lamellar endothelial keratoplasty DEVICE

PureSee™ IOL in combined cataract and lamellar endothelial keratoplasty

Single arm

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bilateral cataract grade greater than II, according to the Lens Opacities Classification System III (LOCS III) , combined with FECD displaying clinical or subclinical corneal edema or displaying visual disturbing guttae with at least Krachmer grade 3
• Patients aged between 40 and 90 years
• Capacity to read and to understand the study information and to provide informed consent, as well as Patient Reported Spectacle Independence Questionnaire (PRSIQ) and Patient Reported Visual Symptom Questionnaire (PRVSQ)
• Patients willing and capable to attend the 6-month follow-up appointment

You may not qualify if:

• history of ocular surgery
• corneal scars
• macular disease revealed by pre-surgical macular Optical Coherence Tomography (OCT),
• opticopathy
• glaucoma with reduced sensitivity of visual field
• uveitis
• amblyopia
• axial length \<22mm or \>25mm,
• scotopic pupil size \>5mm,
• central corneal thickness \>700microns,
• corneal astigmatism \>1 diopters (D) on biometry
• irregular astigmatism (RMS HOA 3mm pupil \>0.3)
• angle kappa \>0.3mm ((chord µ measured with Pentacam HR; Oculus, Wetzlar, Germany)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Mencucci R, Romualdi G, De Vitto C, Cennamo M. Enhanced Monofocal Intraocular Lenses in Fuchs' Endothelial Dystrophy Patients: Results from Triple Descemet Membrane Endothelial Keratoplasty Procedure. Life (Basel). 2024 Feb 9;14(2):243. doi: 10.3390/life14020243.

  PMID: 38398752 BACKGROUND

MeSH Terms

Conditions

Cataract; Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Karolien Termote, MF, Febo

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolien Termote, MD, Febo

CONTACT

+32475878777; karolien.termote@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-01

Locations

BE (1)