Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

Study Overview
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Brief Summary
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Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients as second surgery after failed trabeculotomy or goniotomy.

Detailed Description
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Glaucoma is a chronic, progressive disease, leading to blindness if untreated or insufficiently treated. It is characterized by a loss of optic nerve fiber and a glaucomatous optic disc excavation and, a corresponding pattern of visual field loss. Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). PCG and DG are treated surgically, either by goniotomy or by trabeculotomy as first approach, and not with topical hypotensive medications. Whenever these procedures have failed, the subsequent surgical procedure is usually trabeculectomy with Mitomycin C or the implantation of a glaucoma drainage device. However, there is a lack of evidence regarding the optimal surgical approach after failed goniotomy/trabeculotomy. Optimal treatment in this young group of patients with a long life expectancy is crucial to prevent blindness, allow them to participate in a normal school and work environment, and to minimize disease burdens for these patients and their families as well as to minimize costs for society. Consequently, there is the desire to find a procedure with a superior success rate and even fewer or less severe complications compared to trabeculectomy. Recently, the Santen PRESERFLO was introduced. The results proved fewer complications and comparable efficacy to trabeculectomy, according results presented at scientific meetings. Yet, there are no published studies to compare the both procedures. The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients.

Official Title
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Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

Conditions
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Primary Congenital Glaucoma, Developmental Glaucoma

Intervention / Treatment
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* Device: Santen PRESERFLO MicroShunt
* Procedure: Trabeculectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minors younger than 18 years of age with a diagnosis of Primary Congenital Glaucoma (PCG) or Developmental Glaucoma (DG) will be included participants must have had a failed trabeculotomy or goniotomy (once or twice) or one 360° trabeculotomy. Exclusion Criteria: Individuals with eye pathologies other than glaucoma or, who underwent intraocular surgery within the last 6 months will not be included. patients who will not be willing to proceed with the entire follow-up of 6 months, or whose legal representative did not sign the informed consent will not be enrolled.

Ages Eligible for Study
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Maximum Age: 18 Years

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
Interventional Model Description: Te patients will be randomly assigned in a 1:1 ratio to either (1) Santen PRESERFLO implant (intervention arm) or (2) trabeculectomy (standard therapy) .
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRESERFLO MicroShunt<br>Patients will undergo Santen PRESERFLO MicroShunt implantation with intraoperative use of Mitomycin C 0.2mg/ml for 2 minutes. | Device: Santen PRESERFLO MicroShunt<br>* the PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow<br>|
| Active Comparator: Trabeculectomy<br>Patients will undergo trabeculectomy with intraoperative use of Mitomycin C 0.2mg/ml for 2 minutes. | Procedure: Trabeculectomy<br>* a fornix-based trabeculectomy with a 3x4mm flap will be performed to increase aqueous humor outflow<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy 1 | Change in Goldmann-applanation intraocular pressure (IOP) in mmHg | at 6months compared to baseline (i.e. preop) | 
| Efficacy 2 | Change in the number of drug classes of intraocular pressure (IOP) lowering medications | at 6months compared to baseline (i.e. preop) | 
| Complication rate | rate of intraoperative and postoperative complications (safety) | within 6 months from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exome Sequencing | for known and susprected genes for primary congenital glaucoma or developmental glaucoma as a potential confounder for outcome and rates of complications will be statistically evaluated | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, primary congenital glaucoma, developmental glaucoma