Surgery for Primary Congenital Glaucoma in Neonates

NCT ID: NCT04709497

Last Updated: 2021-01-14

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-07-01

Brief Summary

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The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age.

Detailed Description

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This is a prospective, randomised controlled trial. We plan to recruit 60 infants with primary congenital glaucoma and younger than 1 month of age at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt. Eyes will be randomly assigned to undergo one of 3 surgical interventions: viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab).

The primary outcome of this study is compare the success rate in lowering IOP between the 3 surgical options in infants with Primary Congenital Glaucoma (PCG) below 1 month of age. The secondary clinical outcomes will include Intraocular pressure (IOP), horizontal corneal diameter, axial length, cup-disc ratio, refractive error and postoperative complications in these 3 surgical procedures. Data will be analysed. Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without antiglaucoma drugs (AGD) or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.

Conditions

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Primary Congenital Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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viscotrabeculotomy (VT)).

Group Type ACTIVE_COMPARATOR

viscotrabeculotomy (VT)

Intervention Type PROCEDURE

viscotrabeculotomy (VT)

visco-circumferential-suture-trabeculotomy (VCST)

Group Type ACTIVE_COMPARATOR

visco-circumferential-suture-trabeculotomy (VCST) .

Intervention Type PROCEDURE

visco-circumferential-suture-trabeculotomy (VCST)

Combined VT-Trabeculectomy with MMC (VT-Trab).

Group Type ACTIVE_COMPARATOR

combined VT-Trabeculectomy with MMC (VT-Trab).

Intervention Type PROCEDURE

combined VT-Trabeculectomy with MMC (VT-Trab).

Interventions

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viscotrabeculotomy (VT)

viscotrabeculotomy (VT)

Intervention Type PROCEDURE

visco-circumferential-suture-trabeculotomy (VCST) .

visco-circumferential-suture-trabeculotomy (VCST)

Intervention Type PROCEDURE

combined VT-Trabeculectomy with MMC (VT-Trab).

combined VT-Trabeculectomy with MMC (VT-Trab).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Primary Congenital Glaucoma in Neonates

Exclusion Criteria

secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.
Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Amr Mohammed Elsayed Abdelkader

Lecturer of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amr M Mohammed, MD

Role: CONTACT

1004314242 ext. +20

Other Identifiers

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Viscotrabeculotomy VI

Identifier Type: -

Identifier Source: org_study_id

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