NCT05730478

Brief Summary

Study aiming to compare between anterior segment Optical Coherence Tomography and Ultrasound BioMicroscopy In Glaucoma aSSESMENT

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

January 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

January 31, 2023

Last Update Submit

November 12, 2024

Conditions

Glaucoma Eye

Outcome Measures

Primary Outcomes (1)

  • comparison between Anterior Segment Optical Coherence Tomography And ltrasound Biomicroscopy Parameters In Glaucoma Assesment

    . UBM provides biometric information of anterior segment structures, such as anterior chamber (AC) depth, anterior chamber angle (ACA), and iris thickness. UBM provides more detailed information compared to slit-lamp, gonioscopy or B-scan examinations for diagnosis and follow-up of PAC eyes. It can be used to study the causes of secondary glaucoma. Precise quantitative evaluation of the anterior chamber angle structures can help in diagnosis and management of various pathologies related to glaucoma . anterior segment-optical coherence tomography (AS-OCT) has developed rapidly. With a higher imaging resolution than UBM, AS-OCT makes it easier for the operator and software to identify ACA structures. such as: the scleral spur (SS), iris surface, Schwalbe's line, even trabecular meshwork , and Schlemm's canal. This provides more precise analysis of the angle opening distance from the SS, ACA, trabecular iris angle , and trabecular iris space area

    1 year

Study Arms (1)

ASOCT and UBM parameters Comparison

comparison between ASOCT and UBM parameters in glaucoma ASSESMENT

Device: ASOCT&UBMDrug: Glaucoma therapy

Interventions

ASOCT&UBMDEVICE

glaucoma assesment by ASOCT \&UBM

ASOCT and UBM parameters Comparison
Glaucoma therapyDRUG

ASOCT and UBM parameters Comparison

ASOCT and UBM parameters Comparison

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

comparison between anterior segment optical coherence tomography and ultrasound biomicroscopy parameters in glaucoma assesment

You may qualify if:

  • Patients with open and angle closure glaucoma. Male and female patients were included. Patient age: more than18 years old

You may not qualify if:

  • Previous glaucoma surgery. Previous cataract surgery. Media opacity. Associated ocular or intra ocular inflammation. Associated corneal pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Adel,

Sohag, Egypt

Location

Related Publications (6)

  • Casson RJ, Chidlow G, Wood JP, Crowston JG, Goldberg I. Definition of glaucoma: clinical and experimental concepts. Clin Exp Ophthalmol. 2012 May-Jun;40(4):341-9. doi: 10.1111/j.1442-9071.2012.02773.x. Epub 2012 Apr 5.

    PMID: 22356435BACKGROUND

  • Barkana Y, Dorairaj SK, Gerber Y, Liebmann JM, Ritch R. Agreement between gonioscopy and ultrasound biomicroscopy in detecting iridotrabecular apposition. Arch Ophthalmol. 2007 Oct;125(10):1331-5. doi: 10.1001/archopht.125.10.1331.

    PMID: 17923539BACKGROUND

  • Dada T, Mohan S, Sihota R, Gupta R, Gupta V, Pandey RM. Comparison of ultrasound biomicroscopic parameters after laser iridotomy in eyes with primary angle closure and primary angle closure glaucoma. Eye (Lond). 2007 Jul;21(7):956-61. doi: 10.1038/sj.eye.6702360. Epub 2006 May 5.

    PMID: 16680106BACKGROUND

  • Wirbelauer C, Scholz C, Haberle H, Laqua H, Pham DT. Corneal optical coherence tomography before and after phototherapeutic keratectomy for recurrent epithelial erosions(2). J Cataract Refract Surg. 2002 Sep;28(9):1629-35. doi: 10.1016/s0886-3350(02)01366-4.

    PMID: 12231324BACKGROUND

  • Reinstein DZ, Gobbe M, Archer TJ. Anterior segment biometry: a study and review of resolution and repeatability data. J Refract Surg. 2012 Jul;28(7):509-20. doi: 10.3928/1081597X-20120620-02.

    PMID: 22767168BACKGROUND

  • Sharma R, Sharma A, Arora T, Sharma S, Sobti A, Jha B, Chaturvedi N, Dada T. Application of anterior segment optical coherence tomography in glaucoma. Surv Ophthalmol. 2014 May-Jun;59(3):311-27. doi: 10.1016/j.survophthal.2013.06.005. Epub 2013 Oct 15.

    PMID: 24138894BACKGROUND

Related Links

Study Officials

  • Osama Ali, professor

    Sohag University

    STUDY DIRECTOR

  • Islam Saad, Assistant

    Sohag University

    STUDY DIRECTOR

  • Mohamed Ezz, lecturer

    Sohag University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at ophthalmology department in sohag teaching hospital

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 15, 2023

Study Start

March 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2025

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations

EG(1)