Vitrectomy for Optic Disc Pit Maculopathy | NCT01340703

Studies
Vitrectomy for Optic Disc Pit Maculopathy

NCT01340703

Sponsor

Kyorin University

Status

Completed

Last Update Posted

Apr 22, 2011Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Optic Disc Pit Maculopathy

Interventions

vitrectomy without laser or gas tamponade

Countries

Japan

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Apr 21, 2011

First Submission Date that Met QC Criteria

Apr 21, 2011

First Posted Date

Apr 22, 2011Estimated

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

Apr 21, 2011

Last Update Posted Date

Apr 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or laser photocoagulation to the margin of the optic nerve, for the treatment of macular detachment associated with optic disc pits and to characterize retinal manifestations during treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears to be an effective method of managing macular detachment due to optic disc pits. OCT scanning pre- and postoperatively suggests that peripapillary vitreous traction with the passage of fluid into the retina through the pit is the cause of the schisis-like separation seen in optic disc pit maculopathy.

Detailed Description

Not provided

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

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
optic disc pit maculopathy	Other		Procedure: vitrectomy without laser or gas tamponade

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitrectomy without laser or gas tamponade	Procedure	vitrectomy without laser or gas tamponade	optic disc pit maculopathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anatomical result	resolution of retinal detachment or retinoschisis	one year

Secondary Outcomes

Measure	Description	Time Frame
visual acuity	preoperative and postoperative visual acuity	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

eyes with optic disc pit maculopathy

Exclusion Criteria:

eyes without macular elevation associated with optic disc pit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akito Hirakata, MD	Kyroin University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyroin University Eye Center		Mitaka	Tokyo	181-8611	Japan

Condition Browse Module

MeSH Terms

ID	Term
D012163	Retinal Detachment
D041441	Retinoschisis
D020255	Vitreous Detachment

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D012162	Retinal Degeneration

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy
D007834	Lasers

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative
D055096	Optical Devices
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided