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Internal Limiting Membrane Peeling on Retinal Displacement

NCT ID: NCT04655781

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Internal Limiting Membrane Peeling

Keywords

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Retinal displacement Idiopathic macular hole Internal limiting membrane peeling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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N-T group

ILM was peeled off from nasal retina to temporal retina.

Group Type EXPERIMENTAL

idiopathic macular hole (MH) surgery

Intervention Type PROCEDURE

Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns

T-N group

ILM was peeled off from temporal retina to nasal retina

Group Type EXPERIMENTAL

idiopathic macular hole (MH) surgery

Intervention Type PROCEDURE

Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns

Interventions

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idiopathic macular hole (MH) surgery

Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ILM Peeling

Identifier Type: -

Identifier Source: org_study_id