MedDataX Logo

Visco-Circumferential-Suture-Trabeculotomy Versus Trabeculotomy

NCT ID: NCT04683289

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

comparing outcomes of Visco-Circumferential-Suture-Trabeculotomy in primary congenital glaucoma to trabeculotomy

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

prospective randomized interventional study conducted on infants below the age of 2 years with PCG attending the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University were recruited to compare the long-term surgical outcomes of this proposed technique (VCST) and rigid probe VT in patients with PCG.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Congenital Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Visco-Circumferential-Suture-Trabeculotomy

Visco-Circumferential-Suture-Trabeculotomy

Group Type EXPERIMENTAL

trabeculotomy

Intervention Type PROCEDURE

performing partial unroofing of the SC and viscoelastic injection into the 2 ostia of the canal. This was followed by connecting the scalemm canal to the anterior chamber

viscotrabeculotomy

Viscotrabeculotomy

Group Type ACTIVE_COMPARATOR

trabeculotomy

Intervention Type PROCEDURE

performing partial unroofing of the SC and viscoelastic injection into the 2 ostia of the canal. This was followed by connecting the scalemm canal to the anterior chamber

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

trabeculotomy

performing partial unroofing of the SC and viscoelastic injection into the 2 ostia of the canal. This was followed by connecting the scalemm canal to the anterior chamber

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* infants below the age of 2 years with PCG

Exclusion Criteria

* patients older than 2 years on presentation
* eyes with previous surgery
* eyes with secondary glaucoma
* eyes diagnosed as anterior segment dysgenesis syndrome
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ophthalmic Center

Al Mansurah, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Visco-Suture-Trabeculotomy

Identifier Type: -

Identifier Source: org_study_id