Clinical trial NCT04647929: Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas
Official title: Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Primary Congenital Glaucoma
Developmental Glaucoma
Keywords: glaucoma
primary congenital glaucoma
developmental glaucoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2020-12-01
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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) .
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy 1
timeFrame: at 6months compared to baseline (i.e. preop)
measure: Efficacy 2
timeFrame: at 6months compared to baseline (i.e. preop)
measure: Complication rate
timeFrame: within 6 months from surgery
Secondary outcomes:
measure: Exome Sequencing
timeFrame: at baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: - Individuals with eye pathologies other than glaucoma or, who Töteberg-Harms, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Batlle JF, Fantes F, Riss I, Pinchuk L, Alburquerque R, Kato YP, Arrieta E, Peralta AC, Palmberg P, Parrish RK 2nd, Weber BA, Parel JM. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. J Glaucoma. 2016 Feb;25(2):e58-65. doi: 10.1097/IJG.0000000000000368.
citation: Jayaram H, Scawn R, Pooley F, Chiang M, Bunce C, Strouthidis NG, Khaw PT, Papadopoulos M. Long-Term Outcomes of Trabeculectomy Augmented with Mitomycin C Undertaken within the First 2 Years of Life. Ophthalmology. 2015 Nov;122(11):2216-22. doi: 10.1016/j.ophtha.2015.07.028. Epub 2015 Aug 24.