NCT03185936

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

5.1 years

First QC Date

June 9, 2017

Last Update Submit

June 9, 2017

Conditions

Optic Disc Structural AnomalyMaculopathy

Keywords

optic disc pitretinal detachmentmaculopathy

Outcome Measures

Primary Outcomes (1)

  • anatomical improvement

    Retinal reattachment

    6 months

Secondary Outcomes (1)

  • Functional improvement

    6 months

Study Arms (1)

Optic disc pit maculopathy

EXPERIMENTAL

pars plana vitrectomy with internal limiting membrane (ILM) peeling, endolaser

Procedure: pars plana vitrectomy with internal limiting membrane (ILM) peeling

Interventions

pars plana vitrectomy with internal limiting membrane (ILM) peelingPROCEDURE

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

Also known as: Endolaser photocoagulation
Optic disc pit maculopathy

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular DegenerationRetinal Detachment

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Mahmud Genaidy, MD

    Assistant professor of ophthalmology, ophthalmology department, Minia university, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of ophthalmology

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 14, 2017

Study Start

March 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2017

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Can not be shared