Back to resultsVitrectomy for Optic Disc Pit Maculopathy
Primary Purpose
Optic Disc Pit Maculopathy
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
vitrectomy without laser or gas tamponade
Sponsored by
About this trial
This is an interventional treatment trial for Optic Disc Pit Maculopathy focused on measuring optic disc pit, retinal detachment, retinoschisis, vitrectomy, posterior vitreous detachment
Eligibility Criteria
Inclusion Criteria:
- eyes with optic disc pit maculopathy
Exclusion Criteria:
- eyes without macular elevation associated with optic disc pit
Sites / Locations
- Kyroin University Eye Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
optic disc pit maculopathy
Arm Description
Outcomes
Primary Outcome Measures
anatomical result
resolution of retinal detachment or retinoschisis
Secondary Outcome Measures
visual acuity
preoperative and postoperative visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01340703
Brief Title
Vitrectomy for Optic Disc Pit Maculopathy
Official Title
Vitrectomy Without Laser or Gas Tamponade for Optic Disc Pit Maculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyorin University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Disc Pit Maculopathy
Keywords
optic disc pit, retinal detachment, retinoschisis, vitrectomy, posterior vitreous detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
optic disc pit maculopathy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
vitrectomy without laser or gas tamponade
Intervention Description
vitrectomy without laser or gas tamponade
Primary Outcome Measure Information:
Title
anatomical result
Description
resolution of retinal detachment or retinoschisis
Time Frame
one year
Secondary Outcome Measure Information:
Title
visual acuity
Description
preoperative and postoperative visual acuity
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
eyes with optic disc pit maculopathy
Exclusion Criteria:
eyes without macular elevation associated with optic disc pit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akito Hirakata, MD
Organizational Affiliation
Kyroin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyroin University Eye Center
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Vitrectomy for Optic Disc Pit Maculopathy
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