Visco-Circumferential-Suture-Trabeculotomy Versus Trabeculotomy

Primary Congenital Glaucoma Clinical Trial

Official title:

Surgical Outcomes of Visco-Circumferential-Suture-Trabeculotomy in Primary Congenital Glaucoma: A 3-year Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683289
• Other study ID #: Visco-Suture-Trabeculotomy
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 1, 2020
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Primary Congenital Glaucoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Egypt	Ophthalmic Center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP	intraocular pressure measuring	36 months
Secondary	complications	visual devastating complications	36 months months