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Vitrectomy for Optic Disc Pit Maculopathy

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ClinicalTrials.gov Identifier: NCT01340703
Recruitment Status : Completed
First Posted : April 22, 2011
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
Kyorin University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Optic Disc Pit Maculopathy Procedure: vitrectomy without laser or gas tamponade Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitrectomy Without Laser or Gas Tamponade for Optic Disc Pit Maculopathy
Study Start Date : January 2005
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
optic disc pit maculopathy Procedure: vitrectomy without laser or gas tamponade
vitrectomy without laser or gas tamponade


Outcome Measures
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Primary Outcome Measures :
  1. anatomical result [ Time Frame: one year ]
    resolution of retinal detachment or retinoschisis


Secondary Outcome Measures :
  1. visual acuity [ Time Frame: one year ]
    preoperative and postoperative visual acuity


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Akito Hirakata, Kyorin University
ClinicalTrials.gov Identifier: NCT01340703     History of Changes
Other Study ID Numbers: KyorinEye005
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: January 2011

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