NCT04683289

Brief Summary

comparing outcomes of Visco-Circumferential-Suture-Trabeculotomy in primary congenital glaucoma to trabeculotomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2.1 years

First QC Date

December 19, 2020

Last Update Submit

December 24, 2020

Conditions

Primary Congenital Glaucoma

Outcome Measures

Primary Outcomes (1)

  • IOP

    intraocular pressure measuring

    36 months

Secondary Outcomes (1)

  • complications

    36 months months

Study Arms (2)

Visco-Circumferential-Suture-Trabeculotomy

EXPERIMENTAL

Visco-Circumferential-Suture-Trabeculotomy

Procedure: trabeculotomy

viscotrabeculotomy

ACTIVE COMPARATOR

Viscotrabeculotomy

Procedure: trabeculotomy

Interventions

trabeculotomyPROCEDURE

performing partial unroofing of the SC and viscoelastic injection into the 2 ostia of the canal. This was followed by connecting the scalemm canal to the anterior chamber

Visco-Circumferential-Suture-Trabeculotomyviscotrabeculotomy

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants below the age of 2 years with PCG

You may not qualify if:

  • patients older than 2 years on presentation
  • eyes with previous surgery
  • eyes with secondary glaucoma
  • eyes diagnosed as anterior segment dysgenesis syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Hydrophthalmos

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesGlaucoma, Open-AngleGlaucomaOcular HypertensionCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

December 19, 2020

First Posted

December 24, 2020

Study Start

January 1, 2015

Primary Completion

February 1, 2017

Study Completion

September 1, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)