Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-06-01

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.

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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.

Conditions

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Primary Congenital Glaucoma Developmental Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Te patients will be randomly assigned in a 1:1 ratio to either (1) Santen PRESERFLO implant (intervention arm) or (2) trabeculectomy (standard therapy) .

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRESERFLO MicroShunt

Patients will undergo Santen PRESERFLO MicroShunt implantation with intraoperative use of Mitomycin C 0.2mg/ml for 2 minutes.

Group Type EXPERIMENTAL

Santen PRESERFLO MicroShunt

Intervention Type DEVICE

the PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow

Trabeculectomy

Patients will undergo trabeculectomy with intraoperative use of Mitomycin C 0.2mg/ml for 2 minutes.

Group Type ACTIVE_COMPARATOR

Trabeculectomy

Intervention Type PROCEDURE

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

Interventions

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Santen PRESERFLO MicroShunt

the PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow

Intervention Type DEVICE

Trabeculectomy

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

Intervention Type PROCEDURE

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.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No