Evaluating a Prognostic Score for Visual Recovery After Cataract and Epiretinal Membrane Surgery
Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane
This study is testing a new scoring system to see if it can help predict how well people over 40 will recover their vision after surgery for cataracts and a specific eye condition called epiretinal membrane.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT03329976 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a prognostic score that predicts the likelihood of good visual recovery one year after combined surgery for cataract and idiopathic epiretinal membrane (ERM). The study focuses on patients over 40 years old who have visible idiopathic ERM and are experiencing a decline in visual acuity or disabling metamorphopsia. By assessing clinical and morphological factors, the researchers hope to provide a reliable score that can guide treatment decisions and improve patient outcomes. The study will involve measuring visual acuity post-surgery to evaluate the effectiveness of the prognostic score.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 40 and older with idiopathic ERM who are scheduled for combined cataract and ERM surgery.
Not a fit: Patients with secondary ERM or other significant ocular conditions that could limit visual acuity will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help clinicians better predict visual recovery outcomes for patients undergoing combined cataract and ERM surgery.
How similar studies have performed: While similar studies have explored prognostic factors in ocular surgeries, the specific validation of this prognostic score in the context of combined cataract and ERM surgery is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients presenting idiopathic ERM visible on SD-OCT; * Indication for combined cataract and ERM surgery in a context of a fall in visual acuity or disabling metamorphopsia; * Patients who have provided verbal consent; * Age ≥ 40 years. Exclusion Criteria: * Patients with secondary ERM (Diabetes WITH a history of diabetic retinopathy or maculopathy, occlusion of the retinal veins, uveitis intermediate/posterior uveitis or retinal tear/detachment in the studied eye; * Patient présentant toute autre maculopathie ou neuropathie optique ; * Patient presenting severe myopia (spherical equivalent ≥ 6 diopters or axial length ≥ 26 mm) ; * Patients presenting any other ophthalmological disease independent of the ERM and likely to limit visual acuity * Patients who have already undergone vitrectomy in the studied eye; * Non-visible or poorly visible fundus due to a cloudy vitreous (Signal on OCT Cirrus \<5, Quality score on OCT Spectralis \< 20, signal trend index on OCT Optovue \< 30) * Patients without national health insurance cover * Pregnant or breast-feeding women.
Where this trial is running
Dijon
- CHU Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Yann KAUFFMANN, MD
- Email: yann.kauffmann@hotmail.fr
- Phone: 3 80 29 51 73
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.