Early Vitrectomy for Impending Macular Hole

Retinal Perforation Clinical Trial

Official title:

Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01121965
• Other study ID #: SRIG #1
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2010
• Last updated: March 28, 2011
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: March 2011
• Source: Seoul Retina Investigator Group
• Contact: Se Woong Kang, M.D.
• Phone: 82-2-3410-3562
• Email: swkang[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.

Description:

In a study conducted 15 years ago, the 'Vitrectomy for Prevention of Macular hole Study Group' was not able to prove the benefits and advantages of vitrectomy for impending macular hole; however, during the interim period, notable improvements have been achieved with regard to diagnosis and efficacy of treatment.

Therefore, we designed this study to identify the effect of current vitreous surgery for symptomatic impending macular hole.

Characteristics of this study is as below

• Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole occurs)

• Non-randomized study (decision was made by patients after full explanation)

• After 1 year follow up, functional change(visual acuity)and anatomical change(development of full-thickness macular hole) would be evaluated

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• male or female with impending macular hole(identified with OCT)

• Age: over 45 years

• Symptom duration < 6 Months

• Visual acuity on trial: less than 73 letters in ETDRS chart Visual acuity of worsened eye: over 24 letters in ETDRS chart

Exclusion Criteria:

• Any vision disturbing disease other than impending macular hole

• Diabetic maculopathy or other retinal vascular disease

• Prior history of major trauma: If symptom begins after trauma

• Myopia over -6.5Dioper or eyes with axial length > 28mm

• Evidence of scar, degeneration or exudation of macula

• active intraocular inflammation

• History of intraocular surgery other than uncomplicated cataract extraction 3months before

• Uncontrolled IOP > 25mmHg

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Perforation
• Retinal Perforations

Intervention

Procedure:
• Pars plana vitrectomy with ILM peeling
Pars plana vitrectomy with ILM peeling

Locations

Country	Name	City	State
Korea, Republic of	Konyang University, Myung Gok Eye Research Institute	Daejeon
Korea, Republic of	HanGil Eye Hospital	In Cheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyunggi-do
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul	82-2-3010-3673
Korea, Republic of	Catholic University of Korea	Seoul
Korea, Republic of	Gangnam Sacred Heart Hospital,Hallym University	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital, Hallym University College of Medicine,	Seoul
Korea, Republic of	Kong eye clinic	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul Retina Investigator Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual acuity		48 weeks	No
Secondary	Rate of occurrence of full-thickness macular hole		48 weeks	No