Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

Primary Congenital Glaucoma Clinical Trial

— STOP-Glaucoma  

Official title:

Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04647929
• Other study ID #: STOP Glaucoma
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Developmental Glaucoma
• Glaucoma
• Primary Congenital Glaucoma

Intervention

Device:
• Santen PRESERFLO MicroShunt
the PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Johannes Gutenberg University Mainz

References & Publications (2)

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.000000000 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy 1	Change in Goldmann-applanation intraocular pressure (IOP) in mmHg	at 6months compared to baseline (i.e. preop)
Primary	Efficacy 2	Change in the number of drug classes of intraocular pressure (IOP) lowering medications	at 6months compared to baseline (i.e. preop)
Primary	Complication rate	rate of intraoperative and postoperative complications (safety)	within 6 months from surgery
Secondary	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