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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
Eligibility Criteria
You may qualify if you...
- Requirement for cataract extraction
- Age over 40 years
- Axial length between 21mm and 25mm
- Diagnosis of epiretinal membrane (ERM)
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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