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Glaucoma EyeNCT05730478

Comparison Between Anterior Segment Optical Coherence Tomography and Ultrasound Bio Microscopy Parameters in Glaucoma Assessment

An observational study of Glaucoma Eye, run by Sohag University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Study aiming to compare between anterior segment Optical Coherence Tomography and Ultrasound BioMicroscopy In Glaucoma aSSESMENT Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Glaucoma Eye
What is being tested?
ASOCT&UBM and Glaucoma therapy
Type of treatment
Medical device
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Mar 2023to 1 Jan 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Marwa Adel,

    Sohag

Other trials in Egypt

About this study

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

Read the detailed description

Glaucoma is comprised of a group of optic neuropathies that share certain biological and clinical characteristics including progressive loss of the RGCs that causes specific, irreversible changes to the optic disc and visual field Visualization of the anterior chamber (AC) angle is a critical step in the diagnosis of glaucoma, especially angle-closure variants. .

UBM has been used in imaging and quantitative evaluation of anterior ocular segments since the 1990s. It allows in vivo observation of the anatomy and pathology of the anterior segments, from the conjunctiva and cornea to the iris and basal vitreous body, which provides significant information on glaucoma, cysts, neoplasms, trauma and foreign bodies. UBM also 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.In some cases UBM elucidates the mechanism of elevated intraocular pressure by showing the relationship between the peripheral iris and the trabecular meshwork. It can be used to study the causes of secondary glaucoma, for example, the pigment dispersion syndrome, lens-induced glaucoma, ciliary block, cysts, and solid tumors of the anterior segment. It can also assess the effects of various interventions such as laser iridotomy, trabeculectomy, and non-penetrating drainage surgery. Precise quantitative evaluation of the anterior chamber angle structures can help in diagnosis and management of various pathologies related to glaucoma . Optical coherence tomography (OCT) is a widely used non-invasive fundus imaging technique. Since the first application of OCT in the cornea in 2002], anterior segment-optical coherence tomography (AS-OCT) has developed rapidly. There are two major OCT platforms on the market: time domain-optical coherence tomography (TD-OCT) and spectral (or Fourier) domain-optical coherence tomography (SD/FD-OCT) . 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 (TM), and Schlemm's canal. This provides more precise analysis of the angle opening distance (AOD) from the SS, ACA, trabecular iris angle (TIA), and trabecular iris space area (TISA)

Conditions
Glaucoma Eye
Being tested
ASOCT&UBM, Glaucoma therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASOCT&UBMDevice

    glaucoma assesment by ASOCT \&UBM

  • Glaucoma therapyDrug

    ASOCT and UBM parameters Comparison

  • Glaucoma therapyDrug

    Also called ASOCT

    Comparison

Study groups in NCT05730478
Study groupRoleWhat they receive
ASOCT and UBM parameters Comparisoncomparison between ASOCT and UBM parameters in glaucoma ASSESMENT
Receives: Device: ASOCT&UBM; Drug: Glaucoma therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Dec 2023
  4. Study completion1 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05730478
Sponsor's protocol ID
MAOmar
Status last verified
Nov 2024
First submitted
31 Jan 2023
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22356435

  • 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.

    PubMed 17923539

  • 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.

    PubMed 16680106

  • 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.

    PubMed 12231324

  • 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.

    PubMed 22767168

  • 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.

    PubMed 24138894

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma Eye, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison between Anterior Segment Optical Coherence Tomography And ltrasound Biomicroscopy Parameters In Glaucoma Assesment (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05730478, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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