NCT05332665

Brief Summary

Evaluation of the effect of phacoemulsification and YAG Laser peripheral iridotomy on the anterior chamber angle anatomic parameters in PACG eyes, using anterior segment optical coherence tomography (SS ASOCT) device

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 11, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

March 28, 2022

Last Update Submit

April 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • IOP

    mmhg

    up to 6 months

Secondary Outcomes (1)

  • Corneal endothelial count

    up to 6 months

Study Arms (3)

Angle opening distance (AOD)

The AOD measured as perpendicular distance between anterior iris surface and point at trabecular meshwork at 500 μm anterior to the scleral spur

Device: AS-OCTProcedure: YAG laser PI

Trabecular iris space area (TISA) 500

TISA 500 was measured as an area bounded anteriorly by the AOD 500, posteriorly by a line drawn from the scleral spur perpendicular to the plane of the inner scleral wall to the opposing iris, superiorly by the inner corneoscleral wall, and inferiorly by the iris surface

Device: AS-OCTProcedure: YAG laser PI

Anterior chamber depth (ACD)

The ACD was measured as the perpendicular distance from the corneal endothelium at the corneal apex to the anterior lens surface

Device: AS-OCTProcedure: YAG laser PI

Interventions

AS-OCTDEVICE

Anterior segment optical coherence tomography (AS OCT) is an imaging device that can acquire an anterior segment image using a noncontact method with the patient in a sitting position. This device provides reproducible and quantitative measurements of the AC angle and other anterior segment parameters.

Angle opening distance (AOD)Anterior chamber depth (ACD)Trabecular iris space area (TISA) 500
YAG laser PIPROCEDURE

medical procedure which uses a laser device to create a hole in the iris, thereby allowing aqueous humor to traverse directly from the posterior to the anterior chamber and, consequently, relieve a pupillary block

Angle opening distance (AOD)Anterior chamber depth (ACD)Trabecular iris space area (TISA) 500

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute attack of ACG with phacoemulsification in this eye with YAG laser PI in the other eye

You may qualify if:

  • patients with acute attack of angle closure glaucoma in one eye.
  • Patients fit for phacoemulsification

You may not qualify if:

  • Patients with history of any intraocular surgery. 2- Patients with history of refractive surgery. 3- Patients with diabetic retinal vasculopathy or retinal detachment. 4- Patients with chronic angle closure glaucoma, open angle glaucoma or 2ry glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

mohamed Mahmoud

Minya, Minya Governorate, 61111, Egypt

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • mohamed Salah

    Minia faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 18, 2022

Study Start

January 11, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Not decided

Locations