Surgery for Primary Congenital Glaucoma in Neonates

Primary Congenital Glaucoma Clinical Trial

Official title:

Surgery for Primary Congenital Glaucoma in Neonates:Randomized Controlled Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04709497
• Other study ID #: Viscotrabeculotomy VI
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2021
• Source: Mansoura University
• Contact: Amr M Mohammed, MD
• Phone: 1004314242
• Email: dramrabdelkader[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

Primary Congenital Glaucoma in Neonates

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Glaucoma
• Primary Congenital Glaucoma

Intervention

Procedure:
• viscotrabeculotomy (VT)
viscotrabeculotomy (VT)
• visco-circumferential-suture-trabeculotomy (VCST) .
visco-circumferential-suture-trabeculotomy (VCST)
• combined VT-Trabeculectomy with MMC (VT-Trab).
combined VT-Trabeculectomy with MMC (VT-Trab).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate in lowering intraocular pressure (IOP)	Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without 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.	3 years
Secondary	horizontal corneal diameter	The change in "white to white" corneal diameters in mm measured by caliber.	3 years
Secondary	axial length	The change in axial length in mm measured by ultrasonography.	3 years
Secondary	cup-disc ratio	The change in cup -disc ratio as measured by optical coherence tomography.	3 years
Secondary	refractive error	The change in refractive error as measured by autorefractometer..	3 years