Vitrectomy for Optic Disc Pit Maculopathy

Optic Disc Pit Maculopathy Clinical Trial

Official title:

Vitrectomy Without Laser or Gas Tamponade for Optic Disc Pit Maculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340703
• Other study ID #: KyorinEye005
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: April 21, 2011
• Start date: January 2005
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• eyes with optic disc pit maculopathy

Exclusion Criteria:

• eyes without macular elevation associated with optic disc pit

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Optic Disc Pit Maculopathy

Intervention

Procedure:
• vitrectomy without laser or gas tamponade
vitrectomy without laser or gas tamponade

Locations

Country	Name	City	State
Japan	Kyroin University Eye Center	Mitaka	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anatomical result	resolution of retinal detachment or retinoschisis	one year	No
Secondary	visual acuity	preoperative and postoperative visual acuity	one year	No