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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04802265
Other study ID # RBHP 2021 SILLAIRE
Secondary ID 2021-A00071-40
Status Terminated
Phase
First received
Last updated
Start date May 21, 2021
Est. completion date August 1, 2021

Study information

Verified date October 2023
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - adult up to 18 years old, - diagnosed and treated surgically Exclusion Criteria: - proliferative diabetic retinopathy, - ocular trauma, - central veinous occlusion, - intra-ocular tumor, total retinal detachment, - central visual field loss in glaucomatous patients

Study Design


Intervention

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.

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand Aura

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best corrected visual acuity (BCVA) (metric : LogMAR) BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale. prior to surgery
Primary Best corrected visual acuity (BCVA) (metric : LogMAR) BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale. Day 180
Secondary BCVA at day 15, 1, 3 month. BCVA is measured at each medical appointment. Monoyer Scale is used and. Resulats are converted in LogMAR scale. Day 15, Day 30, Day 90
Secondary near visual acuity measured at baseline, day 15, 1, 3 and 6 month near visual acuity is measured at each medical appointment using Parinaud Scale Day 180
Secondary central retinal thickness (CRT) CRT is measured on optical coherence tomography (OCT) at baseline, day 15, 1 , 3 and 6 months Day 180
Secondary peeling initiation retinal thickness to evaluate the damage due to the membrane gripping during the peeling initiation, retinal thickness is performed at this location by OCT. Day 180
Secondary 10° visual field a 10° Visual Field is performed at baseline, 1 month and 6 month Day 180
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