Implanting functional intraocular lenses in patients with epiretinal membrane
Clinical Outcomes in Cataract Patients With Macular Epiretinal Membrane After Implantation of Functional Intraocular Lenses
This study is testing whether a special type of eye lens can improve vision better than a standard lens for cataract patients with a specific eye condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT06719739 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter study aims to evaluate the impact of different intraocular lenses (IOLs) on visual outcomes in cataract patients diagnosed with grade-1 macular epiretinal membrane (ERM). Patients will be assessed using optical coherence tomography (OCT) and will choose between a standard monofocal IOL and a functional IOL for implantation. The study will follow participants for two years, measuring visual acuity and other ocular parameters to determine the effectiveness of the functional IOL compared to the standard option. Outcome measures include various visual acuity assessments and detailed optical measurements.
Who should consider this trial
Good fit: Ideal candidates are cataract patients over 40 years old with a diagnosis of grade-1 macular epiretinal membrane and an axial length between 21mm and 25mm.
Not a fit: Patients with significant corneal astigmatism, amblyopia, previous ocular surgeries, or other serious ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve visual outcomes for cataract patients with epiretinal membrane by identifying the most effective type of intraocular lens.
How similar studies have performed: While there have been studies on IOLs in cataract surgery, this specific approach focusing on functional IOLs in patients with ERM is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Requirement for cataract extraction * Age \> 40 years * Axial length in 21mm to 25mm * ERM Exclusion Criteria: * 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
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Eye and Ear, Nose, and Throat Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Heping Eye Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jin Yang
- Email: jin_er76@hotmail.com
- Phone: 13671632525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.