Surgery for Primary Congenital Glaucoma in Neonates
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJanuary 14, 2021
January 1, 2021
2 years
January 9, 2021
January 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
success rate in lowering intraocular pressure (IOP)
Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without AGD or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.
3 years
Secondary Outcomes (4)
horizontal corneal diameter
3 years
axial length
3 years
cup-disc ratio
3 years
refractive error
3 years
Study Arms (3)
viscotrabeculotomy (VT)).
ACTIVE COMPARATORvisco-circumferential-suture-trabeculotomy (VCST)
ACTIVE COMPARATORCombined VT-Trabeculectomy with MMC (VT-Trab).
ACTIVE COMPARATORInterventions
visco-circumferential-suture-trabeculotomy (VCST)
combined VT-Trabeculectomy with MMC (VT-Trab).
Eligibility Criteria
You may qualify if:
- Primary Congenital Glaucoma in Neonates
You may not qualify if:
- secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of ophthalmology
Study Record Dates
First Submitted
January 9, 2021
First Posted
January 14, 2021
Study Start
March 1, 2021
Primary Completion
March 1, 2023
Study Completion
July 1, 2023
Last Updated
January 14, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
providing data as supplemental digital content