- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438210
Peeling of the Internal Limiting Membrane During Primary Vitrectomy for Retinal Detachment Repair
Effect of Peeling of the Internal Limiting Membrane on Vision Results After Primary Vitrectomy for Retinal Detachment Repair
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Retinal detachment is a disorder, usually caused by peripheral retinal breaks, that leads to severe decrease in vision in untreated cases. Primary vitrectomy for retinal detachment repair is one of the current methods for surgical treatment of retinal detachment. Recent retrospective studies support the hypothesis, that peeling of the internal limiting membrane (ILM) is beneficial on postoperative visual acuity and lower rates of occurrence of epiretinal membranes after surgery [Forlini et al. 2018].
The aim of the study is to examine the effect of ILM-Peeling on visual acuity outcomes and on occurrence of postoperative epiretinal membranes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1140
- VIROS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- retinal detachment
- age: 18 or older
- written informed consent for surgery and participation in the study prior to surgery
Exclusion Criteria:
- pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ILM-Peeling
|
during primary vitrectomy for retinal detachment repair additional ILM-Peeling is performed
|
|
Active Comparator: No Peeling
|
during primary vitrectomy for retinal detachment repair no additional ILM-Peeling is performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
visual acuity
Time Frame: from enrollment to the end of follow-up at 4 years after surgery
|
from enrollment to the end of follow-up at 4 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
occurrence of epiretinal membranes
Time Frame: from enrollment to the follow-up at 4 years after surgery
|
from enrollment to the follow-up at 4 years after surgery
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD_ILM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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