NCT06445634

Brief Summary

To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

May 31, 2024

Last Update Submit

June 5, 2024

Conditions

Keywords

secodary angle closureGATTintra ocular pressure

Outcome Measures

Primary Outcomes (2)

  • IOP and glaucoma medications.

    measurement of intra ocular pressure and documentation of number of anti glaucoma medications post operative

    1day,1 week,1 months, 3 months, 6 months and 1 year

  • Surgical success.

    Surgical success will be defined as: complete if IOP is less than or equal to 21mmHg without medications and qualified success if IOP is less than or equal to 21mmHg with medications. Failure will be the inability to achieve such a pressure, the need for another glaucoma operation or the development of a sight-threatening complication (e.g., retinal detachment, endophthalmitis)

    1day,1 week,1 months, 3 months, 6 months and 1 year

Secondary Outcomes (1)

  • Complications.

    1day,1 week,1 months, 3 months, 6 months and 1 year

Study Arms (1)

Gatt combined with goinosynechiolysis in secondary synechial angle closure

OTHER

Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure

Other: Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis

Interventions

Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure

Also known as: GATT
Gatt combined with goinosynechiolysis in secondary synechial angle closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with secondary synechial angle closure glaucoma
  • Involving more than 180 degrees of the iridocorneal angle
  • Requiring surgery for uncontrolled IOP despite maximum tolerated therapy.

You may not qualify if:

  • Eyes with PACG.
  • Eyes with neovascular glaucoma. (Some apparently stable NVG cases would have remnants of neo-vessels in the angle that are hidden behind the synechiae).
  • Eyes with retinal pathology.
  • Eyes requiring combined phacoemulsification and GATT.
  • Eyes with corneal pathology that can preclude surgery and imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasralainy Hospitals

Giza, 11555, Egypt

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start

April 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

medical data including intraocular pressure and study outcomes will be shared but excluding any participant confidential data

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After publication within 18 months
Access Criteria
will be uploaded

Locations