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Internal Limiting Membrane Peeling on Retinal Displacement

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ClinicalTrials.gov Identifier: NCT04655781
Recruitment Status : Completed
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Internal Limiting Membrane Peeling Procedure: idiopathic macular hole (MH) surgery Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Displacement of the Retina After Idiopathic Macular Hole Surgery With Different Internal Limiting Membrane Peeling Patterns
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: N-T group
ILM was peeled off from nasal retina to temporal retina.
 Procedure: idiopathic macular hole (MH) surgery
Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns
Experimental: T-N group
ILM was peeled off from temporal retina to nasal retina
 Procedure: idiopathic macular hole (MH) surgery
Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns


Outcome Measures
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Primary Outcome Measures :
  1. T-OD [ Time Frame: preoperation to postoperative 6 months ]
    measurement of temporal vessel to optic disc


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04655781    
Other Study ID Numbers: ILM Peeling
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Retinal displacement
Idiopathic macular hole
Internal limiting membrane peeling
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases