Actively Recruiting

Phase Not Applicable
Age: 20Years - 90Years
All Genders
ID06719739

Clinical Outcomes in Cataract Patients With Macular Epiretinal Membrane After Implantation of Functional Intraocular Lenses

Led by Eye & ENT Hospital of Fudan University · Updated on 2026-04-08

90

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate macular involvement and epiretinal membrane (ERM) grading using OCT in eyes with ERM and to compare clinical outcomes after implanting Enhance intraocular lenses (IOL) versus standard monofocal IOLs in patients with ERM. The study focuses on whether functional IOLs provide benefits for patients with ERM undergoing cataract surgery. It is a prospective, multicenter, interventional study involving cataract patients diagnosed with grade-1 macular ERM. Participants diagnosed with ERM will choose between receiving either a functional IOL or a monofocal IOL during cataract surgery. The follow-up period for the study is two years. The primary outcome is visual acuity measured at various distances (5 meters, 66 cm, and 40 cm) using standard visual acuity charts. Secondary outcomes include OCT and Amsler grid tests, measurements of higher-order aberrations, modulation transfer function, defocus curves, contrast sensitivity under different lighting conditions, reading ability tests, and questionnaires assessing functional vision and photic phenomena. Participants will have scheduled visits at baseline, 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after surgery. At each visit, researchers will perform visual acuity exams, OCT imaging, contrast sensitivity testing, and reading tests. Questionnaires will assess vision-related quality of life and photic symptoms. These assessments help compare the visual outcomes and satisfaction between the functional IOL and monofocal IOL groups throughout the two-year follow-up.

CONDITIONS

Brief Title

Functional IOL Implantation in Patients With Epiretinal Membrane

Who Can Participate

Age: 20Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Requirement for cataract extraction
  • Age over 40 years
  • Axial length between 21mm and 25mm
  • Diagnosis of epiretinal membrane (ERM)
Not Eligible

You will not qualify if you...

  • Residual corneal astigmatism greater than 1.0 diopter
  • Presence of amblyopia
  • Previous ocular surgery
  • Other eye diseases besides macular ERM, such as diabetic retinopathy, macular degeneration, or glaucoma with field defects
  • Need for additional ocular surgery or retinal laser treatments during the study (except Nd:YAG capsulotomy)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants diagnosed with macular epiretinal membrane receive implantation of either functional intraocular lenses or monofocal intraocular lenses based on their choice.

1-day visit (in-person)

Post-operative Follow-up

Duration - 2 years

Participants are monitored with scheduled visits to evaluate visual acuity, objective visual quality, reading ability, and satisfaction over a 2-year period.

Follow-up visits at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years (in-person)

Trial Site Locations

Total: 2 locations

1

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

Shanghai, Shanghai Municipality, China, 200031

Actively Recruiting

2

Shanghai Heping Eye Hospital

Shanghai, Shanghai Municipality, China, 200081

Actively Recruiting

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Research Team

J

Jin Yang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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