Early Vitrectomy for Macular Tractional Maculopathy | NCT01121978

Studies
Early Vitrectomy for Macular Tractional Maculopathy

NCT01121978

Sponsor

Seoul Retina Investigator Group

Status

Unknown status

Last Update Posted

Mar 29, 2011Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Myopia, Degenerative

Interventions

Early vitrectomy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2011Estimated

Completion Date

Nov 2012Estimated

First Submitted Date

Apr 30, 2010

First Submission Date that Met QC Criteria

May 10, 2010

First Posted Date

May 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2011

Last Update Posted Date

Mar 29, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Seoul Retina Investigator GroupNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to identify the effect of current vitreous surgery for symptomatic macular tractional maculopathy.

Characteristics of this study is as below

Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole formation or deterioration of visual acuity occurs)
Non-randomized study (decision was made by patients after full explanation)
After 1 year follow up, functional change(visual acuity)and anatomical change would be evaluated

Detailed Description

Degenerative myopia is relatively common disorder, especially in Korean, Japanese and Chinese.

Choroidal neovascularization is well-noted cause of VA deterioration, but nowadays, with improvement of diagnostic tools, such as OCT, VA deterioration from myopic tractional maculopathy is being concerned as well.

But till now, the necessity of early vitrectomy on MTM is controversial. By now some clinicians prefer conservative treatment, which means pars plana vitrectomy would be postponed till structural change such as macular hole formation is noticed. And the others prefer early vitrectomy, which means pars plana vitrectomy should be performed when the symptom begins.

In this study, investigators try to verify the validity of early vitrectomy comparing conservative treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conservative treatment group	No Intervention	Eyes which do not undergo early vitrectomy at the time of enrollment. Surgical intervention would be performed when full-thickness macular hole or vision deterioration occurs
Early vitrectomy	Experimental	Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling	Procedure: Early vitrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early vitrectomy	Procedure	Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling	Early vitrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best Corrected Visual acuity		48 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female with impending macular hole(identified with OCT)
Age: over 20 years
Symptom duration < 6 Months
Visual acuity on trial: more than 20/320 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
Any evidence of atrophic change, scar or exudation on macula active intraocular inflammation
History of intraocular surgery other than uncomplicated cataract extraction 3 months before
Uncontrolled IOP > 25mmHg

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Se Woong Kang, M.D.	Contact	82-2-3410-6776		swkang@skku.edu
Se Woong Kang	Contact	82234103562		swkang@skku.edu

Overall Officials

Name	Affiliation	Role
Se Woong Kang, M.D.	Seoul Retina Investigator Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center, University of Ulsan College of Medicine	Recruiting	Seoul	82-2-3010-3673	138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D047728	Myopia, Degenerative

Ancestor Terms

ID	Term
D009216	Myopia
D012030	Refractive Errors
D005128	Eye Diseases

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