NCT04019210

Brief Summary

A combination of hypotony, flat anterior chamber and choroidal detachment is the most common complications after filtering surgery. The purpose of this study is to present a new modification in standard trabeculectomy technique to reduce such complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2015

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

4.1 years

First QC Date

July 7, 2019

Last Update Submit

July 11, 2019

Conditions

IOP Decreased

Outcome Measures

Primary Outcomes (1)

  • IOP

    Decreased IOP with normal depth anterior chamber measured by Tonopen

    6 month

Study Arms (1)

MODIFIED TRABECULECTOMY

EXPERIMENTAL

Recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. The dissection through the cornea is carried out with great care, leaving only thin corneal stroma over Descement's membrane. Application of direct heat cautery using a prob Imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm.

Procedure: MODIFIED TRABECULECTOMY

Interventions

MODIFIED TRABECULECTOMYPROCEDURE

Rectangular scleral flap

MODIFIED TRABECULECTOMY

Eligibility Criteria

Age30 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ery glacouma

You may not qualify if:

  • Previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut U

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Ocular Hypotension

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Hassan 58 Lotfy, Professor

CONTACT

01020833002hassaniron57@yahoo.com

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 Professor

Study Record Dates

First Submitted

July 7, 2019

First Posted

July 15, 2019

Study Start

October 1, 2015

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

EG(1)