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Vitrectomy for Optic Disc Pit Maculopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340703
First Posted: April 22, 2011
Last Update Posted: April 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kyorin University
  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: 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

Resource links provided by NLM:


Further study details as provided by Kyorin University:

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


Secondary Outcome Measures:
  • visual acuity [ Time Frame: one year ]
    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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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

Responsible Party: Akito Hirakata, Kyorin University
ClinicalTrials.gov Identifier: NCT01340703     History of Changes
Other Study ID Numbers: KyorinEye005
First Submitted: April 21, 2011
First Posted: April 22, 2011
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