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

Macular Hole Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930369
• Other study ID #: DAILMP-CHINA
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2016
• Last updated: October 11, 2016
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Hole
• Retinal Perforations

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical closure grades in OCT		1 year	No
Secondary	Change of anatomical closure grades in OCT		3 months, 6 months, 1 year	No
Secondary	Change from baseline in BCVA (best corrected visual acuity)		3 months, 6 months, 1 year	No