Early Vitrectomy for Impending Macular Hole

NCT ID: NCT01121965

Last Updated: 2011-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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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

Conditions

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Retinal Perforation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative treatment group

Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole occurs

Group Type NO_INTERVENTION

No interventions assigned to this group

Early vitrectomy

Pars plana vitrectomy with ILM peeling would be employed when visual symptoms occur.

Group Type EXPERIMENTAL

Pars plana vitrectomy with ILM peeling

Intervention Type PROCEDURE

Pars plana vitrectomy with ILM peeling

Interventions

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Pars plana vitrectomy with ILM peeling

Pars plana vitrectomy with ILM peeling

Intervention Type PROCEDURE

Other Intervention Names

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macular hole surgery

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul Retina Investigator Group

NETWORK

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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Se Woong Kang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul Retina Investigator Group

Locations

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Asan Medical Center, University of Ulsan College of Medicine

Seoul, 82-2-3010-3673, South Korea

Site Status RECRUITING

Konyang University, Myung Gok Eye Research Institute

Daejeon, Daejeon, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, South Korea

Site Status RECRUITING

HanGil Eye Hospital

Incheon, In Cheon, South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Kangdong Sacred Heart Hospital, Hallym University College of Medicine,

Seoul, Seoul, South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Catholic University of Korea

Seoul, Seoul, South Korea

Site Status RECRUITING

Gangnam Sacred Heart Hospital,Hallym University

Seoul, Seoul, South Korea

Site Status RECRUITING

Kong eye clinic

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Se Woong Kang, M.D.

Role: CONTACT

82-2-3410-3562

Se Woong Kang

Role: CONTACT

82234103562

Facility Contacts

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Young Hee Yoon, M.D.

Role: primary

82-2-3010-3673

Jong Woo Kim, M.D.

Role: primary

82-42-600-8816

Kyu Hyung Park, M.D

Role: primary

82-31-787-7373

Joonhong Sohn, M.D.

Role: primary

0325033322

Hum Chung, M.D.

Role: primary

82-2-2072-2437

Sung Pyo Park, M.D.

Role: primary

82-2-2224-2274

Se Woong Kang, M.D.

Role: primary

82-2-3410-3562

Won-Ki Lee, M.D.

Role: primary

82-2-2258-2846

Ha Kyoung Kim, M.D.

Role: primary

82-2-829-5193

Eun Goo Lee, M.D.

Role: primary

02-480-5000

Other Identifiers

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SRIG #1

Identifier Type: -

Identifier Source: org_study_id

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