Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery

The purpose of this study is to determine the effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).

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Key information

Conditions

Macular Hole Eye Diseases Retinal Diseases Retinal Perforations

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with IMH
patients signed the informed consent form (ICF)
patients with course of IMH less than 3 years

Exclusion criteria

patients with hyper myopia
patients with traumatic macular hole
accompanied or secondary of other fundus disease
open or reopen after receiving MH surgery
patients with retinal detachment
received vitrectomy due to other diseases
glaucoma cannot be controled by medication
patients with other retinal or choroidal disease that may affect VA
poor patients compliance
poor condition that cannot undertake the surgery
dioptric media opacities which make it difficult to exam fundus or measure on OCT

Treatment and study plan

ILM peeling surgery

Procedure

4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)

Primary outcomes

Anatomical closure grades in OCT

Time frame: 1 year

Secondary outcomes

Change of anatomical closure grades in OCT

Time frame: 3 months, 6 months, 1 year
Change from baseline in BCVA (best corrected visual acuity)

Time frame: 3 months, 6 months, 1 year

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 12, 2016
Registry last updated: Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed