Study of Surgery in Patients With Idiopathic Macular Hole

Surgery Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02905409
• Other study ID #: ILMIMH-CHINA
• Status: Recruiting
• Phase: Phase 4
• Start date: August 31, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2019
• Source: Peking University People's Hospital
• Contact: Mingwei Zhao, M.D
• Phone: 13801057408
• Email: dr_mingweizhao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: June 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Macular Hole
• Retinal Perforations
• Surgery

Intervention

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

Locations

Country	Name	City	State
China	People's Hospital of Peking University	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Hospital, Beijing Tongren Hospital, Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical closure grades in OCT	The anatomical outcomes were defined as good closure and poor closure.	6 months
Primary	Change of anatomical closure grades in OCT	The anatomical outcomes were defined as good closure and poor closure.	1 month, 3 months, 6 months, 1 year
Secondary	Change from baseline in BCVA (best corrected visual acuity).	BCVA were measured by ETDRS chart.	1 month, 3 months, 6 months, 1 year