Surgery for Primary Congenital Glaucoma in Neonates

Study Overview
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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.

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

Conditions
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Primary Congenital Glaucoma

Intervention / Treatment
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* Procedure: viscotrabeculotomy (VT)
* Procedure: visco-circumferential-suture-trabeculotomy (VCST) .
* Procedure: combined VT-Trabeculectomy with MMC (VT-Trab).


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: viscotrabeculotomy (VT)).<br> | Procedure: viscotrabeculotomy (VT)<br>* viscotrabeculotomy (VT)<br>|
| Active Comparator: visco-circumferential-suture-trabeculotomy (VCST)<br> | Procedure: visco-circumferential-suture-trabeculotomy (VCST) .<br>* visco-circumferential-suture-trabeculotomy (VCST)<br>|
| Active Comparator: Combined VT-Trabeculectomy with MMC (VT-Trab).<br> | Procedure: combined VT-Trabeculectomy with MMC (VT-Trab).<br>* combined VT-Trabeculectomy with MMC (VT-Trab).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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