NCT03917602

Brief Summary

This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

May 11, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

April 14, 2019

Last Update Submit

March 23, 2020

Conditions

Macular Holes

Keywords

Human amniotic membrane; large macular holes

Outcome Measures

Primary Outcomes (1)

  • closure of the macular hole

    closure of the macular hole as shown by optical coherence tomography

    at the 6 month follow up visit

Study Arms (1)

Patients with large macular holes

EXPERIMENTAL

Patients suffering from large macular holes as documented by spectral domain OCT will undergo pars plan vitrectomy with human amniotic membrane insertion into the macular hole.

Procedure: human amniotic membrane plug with vitrectomy

Interventions

human amniotic membrane plug with vitrectomyPROCEDURE

using human amniotic membrane plug with vitrectomy to try to close large macular hole

Also known as: human amniotic membrane plug with vitrectomy for closure of large macular holes
Patients with large macular holes

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • large macular hole confirmed by optical coherence tomography

You may not qualify if:

  • patients who had diabetic retinopathy, vascular occlusion, retinal neovascularization, inflammatory disease and optic atrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Egypt

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

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

Study Record Dates

First Submitted

April 14, 2019

First Posted

April 17, 2019

Study Start

May 11, 2019

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

optical coherence tomography data of patients pre and postoperatively may be shared with other researchers

Shared Documents
STUDY PROTOCOL
Time Frame
after start of recruiting patients

Locations

EG(1)