Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

NCT04647929 | Withdrawn DMC

• 1 other identifier: STOP Glaucoma
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Congenital Glaucoma; Developmental Glaucoma

Keywords

glaucoma; primary congenital glaucoma; developmental glaucoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Exome Sequencing

  at baseline

Study Arms (2)

PRESERFLO MicroShunt

EXPERIMENTAL

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

Device: Santen PRESERFLO MicroShunt

Trabeculectomy

ACTIVE COMPARATOR

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

Procedure: Trabeculectomy

Interventions

Santen PRESERFLO MicroShunt DEVICE

the PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow

PRESERFLO MicroShunt

Trabeculectomy PROCEDURE

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

Trabeculectomy

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead
• Johannes Gutenberg University Mainz: collaborator

Related 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.0000000000000368.

  PMID: 26766400 RESULT

• 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.

  PMID: 26315044 RESULT

MeSH Terms

Conditions

Hydrophthalmos; Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Glaucoma, Open-Angle; Ocular Hypertension; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• - Individuals with eye pathologies other than glaucoma or, who Töteberg-Harms, MD, FEBO

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 1, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share