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Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

NCT04647929 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-06-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2020-12-01
Completion
2023-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647929 on ClinicalTrials.gov