Vitrectomy for Optic Disc Pit Maculopathy

This study has been completed.
Sponsor:
Information provided by:
Kyorin University
ClinicalTrials.gov Identifier:
NCT01340703
First received: April 21, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Optic Disc Pit Maculopathy
Procedure: vitrectomy without laser or gas tamponade

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitrectomy Without Laser or Gas Tamponade for Optic Disc Pit Maculopathy

Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • anatomical result [ Time Frame: one year ] [ Designated as safety issue: No ]
    resolution of retinal detachment or retinoschisis


Secondary Outcome Measures:
  • visual acuity [ Time Frame: one year ] [ Designated as safety issue: No ]
    preoperative and postoperative visual acuity


Enrollment: 8
Study Start Date: January 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
optic disc pit maculopathy Procedure: vitrectomy without laser or gas tamponade
vitrectomy without laser or gas tamponade

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • eyes with optic disc pit maculopathy

Exclusion Criteria:

  • eyes without macular elevation associated with optic disc pit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340703

Locations
Japan
Kyroin University Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Akito Hirakata, MD Kyroin University
  More Information

No publications provided

Responsible Party: Akito Hirakata, Kyorin University
ClinicalTrials.gov Identifier: NCT01340703     History of Changes
Other Study ID Numbers: KyorinEye005
Study First Received: April 21, 2011
Last Updated: April 21, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
optic disc pit
retinal detachment
retinoschisis
vitrectomy
posterior vitreous detachment

ClinicalTrials.gov processed this record on September 16, 2014