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

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.

Study Overview

• Status: Withdrawn
• Conditions: Primary Congenital Glaucoma; Developmental Glaucoma
• Intervention / Treatment: Device: Santen PRESERFLO MicroShunt; Procedure: Trabeculectomy

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: - Individuals with eye pathologies other than glaucoma or, who Töteberg-Harms, MD, FEBO, University of Zurich

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2020
• Primary Completion (Estimated): December 1, 2020
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: glaucoma; primary congenital glaucoma; developmental glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Glaucoma, Open-Angle; Infant, Newborn, Diseases; Glaucoma; Hydrophthalmos
• Other Study ID Numbers: STOP Glaucoma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No