Internal Limiting Membrane Peeling on Retinal Displacement
Primary Purpose
Internal Limiting Membrane Peeling
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
idiopathic macular hole (MH) surgery
Sponsored by
About this trial
This is an interventional treatment trial for Internal Limiting Membrane Peeling focused on measuring Retinal displacement, Idiopathic macular hole, Internal limiting membrane peeling
Eligibility Criteria
Inclusion Criteria:
Eyes with idiopathic macular hole
Exclusion Criteria:
Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
N-T group
T-N group
Arm Description
ILM was peeled off from nasal retina to temporal retina.
ILM was peeled off from temporal retina to nasal retina
Outcomes
Primary Outcome Measures
T-OD
measurement of temporal vessel to optic disc
Secondary Outcome Measures
Full Information
NCT ID
NCT04655781
First Posted
November 30, 2020
Last Updated
November 30, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04655781
Brief Title
Internal Limiting Membrane Peeling on Retinal Displacement
Official Title
Displacement of the Retina After Idiopathic Macular Hole Surgery With Different Internal Limiting Membrane Peeling Patterns
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate displacement of the retina after idiopathic macular hole surgery with different internal limiting membrane peeling patterns.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. All patients with idiopathic MH will be randomly allocated into two groups, N-T group or T-N group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internal Limiting Membrane Peeling
Keywords
Retinal displacement, Idiopathic macular hole, Internal limiting membrane peeling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-T group
Arm Type
Experimental
Arm Description
ILM was peeled off from nasal retina to temporal retina.
Arm Title
T-N group
Arm Type
Experimental
Arm Description
ILM was peeled off from temporal retina to nasal retina
Intervention Type
Procedure
Intervention Name(s)
idiopathic macular hole (MH) surgery
Intervention Description
Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns
Primary Outcome Measure Information:
Title
T-OD
Description
measurement of temporal vessel to optic disc
Time Frame
preoperation to postoperative 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eyes with idiopathic macular hole
Exclusion Criteria:
Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internal Limiting Membrane Peeling on Retinal Displacement
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