Vitrectomy for Optic Disc Pit Maculopathy

• Sponsor: Kyorin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01340703
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 72
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Optic Disc Pit Maculopathy	Procedure: vitrectomy without laser or gas tamponade	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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: Jan 1, 2005
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: optic disc pit maculopathy	Procedure: vitrectomy without laser or gas tamponade; vitrectomy without laser or gas tamponade

Outcome Measures

Primary Outcome Measures

1. anatomical result [one year]

   resolution of retinal detachment or retinoschisis

Secondary Outcome Measures

1. visual acuity [one year]

   preoperative and postoperative visual acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• eyes with optic disc pit maculopathy

Exclusion Criteria:

• eyes without macular elevation associated with optic disc pit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyroin University Eye Center	Mitaka	Tokyo	Japan	181-8611

Sponsors and Collaborators

• Kyorin University

Investigators

• Principal Investigator: Akito Hirakata, MD, Kyroin University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01340703
• Other Study ID Numbers: KyorinEye005
• First Posted: Apr 22, 2011
• Last Update Posted: Apr 22, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: optic disc pit; retinal detachment; retinoschisis; vitrectomy; posterior vitreous detachment
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Apr 22, 2011