Surgery for Primary Congenital Glaucoma in Neonates

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04709497

Enrollment

Registered

2021-01-14

Start date

2021-03-01

Completion date

2023-07-01

Last updated

2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Congenital Glaucoma

Brief 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.

Detailed 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.

Interventions

PROCEDUREviscotrabeculotomy (VT)

viscotrabeculotomy (VT)

PROCEDUREvisco-circumferential-suture-trabeculotomy (VCST) .

visco-circumferential-suture-trabeculotomy (VCST)

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 30 Days

Healthy volunteers

Inclusion criteria

Primary Congenital Glaucoma in Neonates

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
success rate in lowering intraocular pressure (IOP)	3 years	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.

Secondary

Measure	Time frame	Description
horizontal corneal diameter	3 years	The change in white to white corneal diameters in mm measured by caliber.
axial length	3 years	The change in axial length in mm measured by ultrasonography.
cup-disc ratio	3 years	The change in cup -disc ratio as measured by optical coherence tomography.
refractive error	3 years	The change in refractive error as measured by autorefractometer..

Contacts

Primary ContactAmr M Mohammed, MD

dramrabdelkader@gmail.com1004314242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026