Study of Surgery in Patients With Idiopathic Macular Hole

A Randomized, Double-masked, Multicenter, Controlled Study of Effects of Internal Membrane Peeling Surgery in Patients With Idiopathic Macular Hole Measured by Optical Coherence Tomography.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02905409

Enrollment

228

Registered

2016-09-19

Start date

2016-08-31

Completion date

2020-06-30

Last updated

2019-12-30

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

Conditions

Idiopathic Macular Hole, Surgery

Brief summary

The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.

Detailed description

The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.

Interventions

PROCEDUREILM peeling surgery

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Inclusion criteria

* patients with IMH * patients signed the 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

Measure	Time frame	Description
Anatomical closure grades in OCT	6 months	The anatomical outcomes were defined as good closure and poor closure.
Change of anatomical closure grades in OCT	1 month, 3 months, 6 months, 1 year	The anatomical outcomes were defined as good closure and poor closure.

Secondary

Measure	Time frame	Description
Change from baseline in BCVA (best corrected visual acuity).	1 month, 3 months, 6 months, 1 year	BCVA were measured by ETDRS chart.

Countries

China

Contacts

Primary ContactMingwei Zhao, M.D

dr_mingweizhao@163.com13801057408

Outcome results

None listed

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