Surgical Management of Optic Disc Pit Maculaopathy

Maculopathy Clinical Trial

Official title:

Pars Plana Vitrectomy With Internal Limiting Membrane Peeling in Optic Disc Pit Maculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185936
• Other study ID #: ODP-M
• Status: Completed
• Phase: N/A
• First received: June 9, 2017
• Last updated: June 9, 2017
• Start date: March 1, 2011
• Est. completion date: April 1, 2017

Study information

• Verified date: June 2017
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

Description:

As it is well known, optic disc pit (ODP) is a rare congenital disease which is usually associated with maculopathy (ODP-M) in the form of intraretinal and subretinal fluid accumulation at the macular area leading to visual impairment.

With no definite treatment and absence of guidelines for its management, the invistigators considered their prospective, interventional case series to evaluate the anatomical and functional results of pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients included in this study are those with ODP associated with macular detachment

Exclusion Criteria:

• Exclusion criteria included patients unfit for general anesthesia, those with insufficient clear media to perform the surgery with ILM peeling and those with other ocular diseases that can affect central macular thickness (CMT) and the best corrected visual acuity (BCVA).

Related Conditions & MeSH terms

• Eye Abnormalities
• Maculopathy
• Optic Disc Structural Anomaly

Intervention

Procedure:
• pars plana vitrectomy with internal limiting membrane (ILM) peeling
pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anatomical improvement	Retinal reattachment	6 months
Secondary	Functional improvement	Visual acuity letters gain	6 months