Early Vitrectomy for Impending Macular Hole

Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01121965

Enrollment

Registered

2010-05-12

Start date

2009-11-30

Completion date

2012-11-30

Last updated

2011-03-29

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

Conditions

Retinal Perforation

Keywords

macular hole, impending macular hole, stage 1 macular hole

Brief summary

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

Detailed 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

Interventions

PROCEDUREPars plana vitrectomy with ILM peeling

Pars plana vitrectomy with ILM peeling

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Best Corrected Visual acuity	48 weeks

Secondary

Measure	Time frame
Rate of occurrence of full-thickness macular hole	48 weeks

Countries

South Korea

Contacts

Primary ContactSe Woong Kang, M.D.

swkang@skku.edu82-2-3410-3562

Backup ContactSe Woong Kang

swkang@skku.edu82234103562

Outcome results

None listed

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