NCT04278079

Brief Summary

Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

4.9 years

First QC Date

February 12, 2020

Last Update Submit

February 19, 2020

Conditions

Myopic Traction MaculopathyPars Plana VitrectomyInternal Limiting Membrane Peeling

Outcome Measures

Primary Outcomes (1)

  • Improvement of best corrected visual acuity

    6 months

Interventions

Pars Plana Vitrectomy with Internal Limiting Membrane peelPROCEDURE

Pars plana vitrectomy with staining and peeling of internal limiting membrane

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 Diopter, or an axial length more than 26.5 mm.
  • Best Corrected Visual Acuity less than 0.1
  • Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane
  • At least 6 months follow-up

You may not qualify if:

  • Eyes with diffuse chorioretinal macular atrophy
  • Concomitant presence of a choroidal neovascular membrane
  • Young patients less than 21 years old.
  • History of trauma
  • Dense media opacity (corneal/ lenticular)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Clinical Associate Professor

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 20, 2020

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share