Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

University of Zurich

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Primary Congenital Glaucoma Developmental Glaucoma

Interventions

Santen PRESERFLO MicroShuntDEVICE

the PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow

TrabeculectomyPROCEDURE

a fornix-based trabeculectomy with a 3x4mm flap will be performed to increase aqueous humor outflow

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Efficacy 1

Change in Goldmann-applanation intraocular pressure (IOP) in mmHg

Time frame: at 6months compared to baseline (i.e. preop)

Efficacy 2

Change in the number of drug classes of intraocular pressure (IOP) lowering medications

Time frame: at 6months compared to baseline (i.e. preop)

Complication rate

rate of intraoperative and postoperative complications (safety)

Time frame: within 6 months from surgery

Secondary Outcomes

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

Time frame: at baseline

Data from ClinicalTrials.gov

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