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TerminatedNCT03329976PROCATMERUpdated Feb 4, 2026

Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane

An observational study in Surgery for Cataract and Surgery for and Idiopathic Epiretinal Membrane, sponsored by Centre Hospitalier Universitaire Dijon. Terminated at 1 site in France. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Why this study was terminated
due to lack of recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
164
Ages
40 Years and older
Sex
All
01

Study summary

The prevalence of idiopathic epiretinal membranes (ERM) in people over 50 is estimated at 6 to 19%. Even though most cases show very few symptomats, they may induce alterations of the underlying retina and lead to visual impairment likely to greatly diminish quality of life in patients. Thanks to the ever-improving quality of vitreo-retinal surgery, ablation of these membranes is a frequent and safe procedure allowing a functional gain in the majority of cases. Given the increasing prevalence in the population concerned and the accelerated ageing of the lens after vitrectomy, cataract surgery is often associated with removal of the membrane. On the basis of a study in 142 patients, it was possible to identify clinical and morphological prognostic factors and to inclure them in a score to assess the chances of complete functional recovery at one year following the procedure . Age of the patient, the duration of symptoms, initial visual acuity and the quality of the junction between external and internal segments of photoreceptors in optic coherence tomography (OCT) appeared as significantly related to visual results. Using this score in a new prospective cohort would allow the investigators to make it a reliable and easy-to-use tool at the service of ophthalmologist surgeons and their patients and would provide scientific confirmation of the interest of earlier surgery in this disease. It would also allow the investigators to define in a validated and reproducible manner, a threshold for an ndication for ERM surgery, which is currently based on relatively subjective criteria mostly related to visual acuity.

02

Conditions studied

  • Surgery for Cataract
  • Surgery for and Idiopathic Epiretinal Membrane
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In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 164 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

any person about to undergo combined surgery for cataract and ERM

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
164 participants (actual)
Patient registry
No

Groups and cohorts

  • patient

    any person about to undergo combined surgery for cataract and ERM

    Other: measurement of visual acuity

Interventions

  • Othermeasurement of visual acuity

    complete ophthalmologic examination of a macular SD-OCT, a fundus of eye, evaluation of the vision of contrasts (Pelli-Robson test) and quantification of metamorphopsies (M-Charts);

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What researchers measure

Primary outcomes

  1. scale of monoyer at 5 meter

    Time frame: over the 12 months of follow-up

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Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03329976
Responsible party
Sponsor
First posted
Nov 6, 2017
Start date
Apr 3, 2018
Primary completion
Jan 5, 2026
Completion
Jan 5, 2026
Last update
Feb 4, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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