Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas (STOP-Glaucoma)

University of Zurich (UZH)

Status

Withdrawn

Conditions

Primary Congenital Glaucoma

Developmental Glaucoma

Treatments

Device: Santen PRESERFLO MicroShunt

Procedure: Trabeculectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04647929

STOP Glaucoma

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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.