Clinical trial NCT01121965: Early Vitrectomy for Impending Macular Hole
Official title: Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Perforation
Keywords: macular hole
impending macular hole
stage 1 macular hole
Lead sponsor: Seoul Retina Investigator Group
Sponsor class: NETWORK
First posted: 2010-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Best Corrected Visual acuity
timeFrame: 48 weeks
Secondary outcomes:
measure: Rate of occurrence of full-thickness macular hole
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
state: 82-2-3010-3673
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
city: Daejeon
country: Korea, Republic of
facility: Konyang University, Myung Gok Eye Research Institute
city: In Cheon
country: Korea, Republic of
facility: HanGil Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital, Hallym University College of Medicine,
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Gangnam Sacred Heart Hospital,Hallym University
city: Seoul
country: Korea, Republic of
facility: Kong eye clinic
Study officials:
affiliation: Seoul Retina Investigator Group
name: Se Woong Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: