Trials / Terminated
TerminatedNCT04802265
EpiRetinal Membrane Peeling and Internal Limiting Membrane
To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- University Hospital, Clermont-Ferrand · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.
Detailed description
This prospective cohort study includes 2 arms : with and without internal limiting membrane (ILM) peeling. Each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ILM. If the ILM is removed in same time : the patient is ranked in the "ILM peeling" group If the ILM is not removed : the patient is ranked in the "non ILM peeling" group. If the ILM is partially removed, the patient is not enrolled. The outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Epiretinal membrane surgery | The surgery consists of a 23 or 25-gauge pars plana vitrectomy (PPV). The surgery was performed peri-bulbar anesthesia and could be combined with phacoemulsification. An intraocular dye is used to well visualized and facilitate ERM peeling. The ILM is not actively peeled. A search for iatrogenic breaks is performed towards the end of the procedure. Areas suspicious for breaks are treated with cryotherapy or peripheral endolaser. |
Timeline
- Start date
- 2021-05-21
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2021-03-17
- Last updated
- 2023-10-23
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04802265. Inclusion in this directory is not an endorsement.