Functional IOL Implantation in Patients With Epiretinal Membrane

NCT06719739 | Recruiting FDA Device

• 1 other identifier: Mild ERM and IOL Implantation
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

We have designed this prospective study to evaluate macular involvement and epiretinal membrane (ERM) grading by OCT in eyes with ERM and to compare clinical outcomes after implantation of Enhance IOL with standard monofocal IOL in eyes with ERM grading preoperatively, aiming to find out whether functional IOL is benefit for patients with ERM.

Conditions

Epiretinal Membrane; Cataract; Intraocular Lens Complication

Outcome Measures

Primary Outcomes (1)

• UDVA

  Uncorrected distance visual acuity

  1-day/1-week/1-month/3-months/6-monhts/1-year/2-years

Study Arms (2)

Functional IOL

EXPERIMENTAL

Experimental group

Device: Intraocular lens implantation

Monofocal IOL

OTHER

Control Group

Device: Intraocular lens implantation

Interventions

Intraocular lens implantation DEVICE

Cataract patients scheduled for surgery will be evaluated by OCT, and those diagnosed with macular epiretinal membrane will be implanted in different IOLs according to the patients' decision: monodical IOL or functional IOL.

Functional IOL; Monofocal IOL

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requirement for cataract extraction
• Age \> 40 years
• Axial length in 21mm to 25mm
• ERM

You may not qualify if:

• Residual corneal astigmatism \> 1.0 D
• Amblyopia
• Previous ocular surgery
• Other ocular pathologies apart from mERM, such as diabetic retinopathy, macular degeneration, glaucoma with field defects
• Requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (2)

Eye and Ear, Nose, and Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Shanghai Heping Eye Hospital

Shanghai, Shanghai Municipality, 200081, China

RECRUITING

MeSH Terms

Conditions

Cataract; Epiretinal Membrane

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Jin Yang

CONTACT

13671632525; jin_er76@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 6, 2024
• Study Start: September 21, 2024
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): September 21, 2026
• Last Updated: April 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)