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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02930369
Enrollment
128
Registered
2016-10-12
Start date
2015-06-30
Completion date
2016-10-31
Last updated
2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Hole

Brief summary

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).

Interventions

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

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Anatomical closure grades in OCT1 year

Secondary

MeasureTime frame
Change of anatomical closure grades in OCT3 months, 6 months, 1 year
Change from baseline in BCVA (best corrected visual acuity)3 months, 6 months, 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026