Surgery for CataractPROCATMERNCT03329976
Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane
An observational study of Surgery for Cataract and Surgery for and Idiopathic Epiretinal Membrane, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Surgery for Cataract, Surgery for and Idiopathic Epiretinal Membrane
- What is being tested?
- measurement of visual acuity
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2018to 5 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any person about to undergo combined surgery for cataract and ERM
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- measurement of visual acuity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of visual acuityOther
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);
| Study group | Role | What they receive |
|---|---|---|
| patient | any person about to undergo combined surgery for cataract and ERM Receives: Other: measurement of visual acuity |
What is being measured
The primary outcome is the main question the study is designed to answer.
scale of monoyer at 5 meter
Measured: over the 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start3 Apr 2018
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Why it stopped: due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery for CataractStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329976
- Sponsor's protocol ID
- KAUFFMANN PHRCI 2016
- Acronym
- PROCATMER
- Status last verified
- Feb 2026
- First submitted
- 13 Oct 2017
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Prognostic Score for Good Visual Recovery at One Year Following Combined Surgery for Cataract and Idiopathic Epiretinal Membrane
- ClinicalTrials.gov ID
- NCT03329976
- Acronym / sponsor ID
- PROCATMER / KAUFFMANN PHRCI 2016
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to lack of recruitment
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: measurement of visual acuityany person about to undergo combined surgery for cataract and ERM |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any person about to undergo combined surgery for cataract and ERM
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of visual acuitycomplete 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); | Other | patient |
Primary outcome
scale of monoyer at 5 meter
Time frame: over the 12 months of follow-up
Results and safety
The study was stopped early (reason given: due to lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery for Cataract and Surgery for and Idiopathic Epiretinal Membrane, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scale of monoyer at 5 meter (time frame: over the 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.