Assessment of Corneal Stiffness in Keratoconus After Crosslinking by Corvis ST and OCT.

NCT05161052 | Unknown

• 1 other identifier: MD-80-2021
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives:

• Measurement of corneal stiffness parameters { Deformation Amlitude (DAR1), Integrated radius, Stress parameter (SP A1), Stress strain index (SSI) and Corvis biomechanical index (CBI) } in keratoconic corneas before and after 3 and 6 months CXL using Corvis ST.
• Measurement of demarcation line depth using anterior segment OCT and correlate between corneal stiffness following CXL and demarcation line depth.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• Measuring changes in corneal stiffness parameters in keratoconus after CXL by Corvis ST which measures corneal stiffness parameters.

  Measurement of changes in corneal stiffness parameters { Deformation Amplitude (DAR1), Integrated radius, Stress parameter (SP A1), Stress strain index (SSI) and Corvis biomechanical index (CBI) } before and after crosslinking procedure to measure corneal stiffness.

  Before crosslinknig procedure and after 3, 6 months using Corvis ST.

Other Outcomes (1)

• Measuring demarcation line depth in microns by anterior segment OCT. in keratoconus after CXL with demarcation line depth in microns by anterior segment OCT.

  After 3 and 6 months using anterior segment OCT

Interventions

Corvis ST (dynamic Scheimpflug technology) DEVICE

* Measurement of corneal stiffness parameters { Deformation Amlitude (DAR1), Integrated radius, Stress parameter (SP A1), Stress strain index (SSI) and Corvis biomechanical index (CBI) } in keratoconic corneas before and after 3 and 6 months CXL using Corvis ST. * Measurement of demarcation line depth using anterior segment OCT and correlate between corneal stiffness following CXL and demarcation line depth

Also known as: OCT (Optical Coherence tomography)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Patients between 18- 40 years old with progressive keratoconus undergoing CXL.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with documented progressive keratoconus within one year include any of the following:
• A. ≥ 1.00 diopter increase in maximal keratometry (Kmax). B. ≥ 1.00 diopter increase in the manifest cylinder. C. ≥ 0.75 diopter increase in average of Kmax and Kmin (Kmean). D. ≥ 2% decrease in central thickness. E. ≥ 1.50 diopter increase in the central K power from baseline. F. ≥ 1.0 diopter increase in manifest spherical equivalent change (MRSE).
• All patients have minimal corneal stromal thickness 400 μm before UVA irradiation.

You may not qualify if:

• Patients with corneal rings.
• Advanced keratoconus with corneal scarring.
• History of herpetic keratitis and severe corneal infection.
• Pregnancy or breastfeeding.
• The use of rigid contact lens¬es for more than 4 weeks before the baseline evaluation.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• Salouti R, Bagheri M, Shamsi A, Zamani M. Corneal Parameters in Healthy Subjects Assessed by Corvis ST. J Ophthalmic Vis Res. 2020 Feb 2;15(1):24-31. doi: 10.18502/jovr.v15i1.5936. eCollection 2020 Jan-Mar.

  PMID: 32095205 BACKGROUND

• Nakao Y, Kiuchi Y, Okumichi H. Evaluation of biomechanically corrected intraocular pressure using Corvis ST and comparison of the Corvis ST, noncontact tonometer, and Goldmann applanation tonometer in patients with glaucoma. PLoS One. 2020 Sep 23;15(9):e0238395. doi: 10.1371/journal.pone.0238395. eCollection 2020.

  PMID: 32966284 BACKGROUND

• Herber R, Terai N, Pillunat KR, Raiskup F, Pillunat LE, Sporl E. [Dynamic Scheimpflug Analyzer (Corvis ST) for measurement of corneal biomechanical parameters : A praxis-related overview]. Ophthalmologe. 2018 Aug;115(8):635-643. doi: 10.1007/s00347-018-0716-y. German.

  PMID: 29767348 BACKGROUND

MeSH Terms

Conditions

Keratoconus

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Mohamed Fakhry, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Elnoamany, MD

CONTACT

01222536367; mohamedelnoamany1@gmail.com

Mohamed Fakhry, MD

CONTACT

01006678788; fakhryref@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * Measurement of corneal stiffness parameters { Deformation Amplitude (DAR1), Integrated radius, Stress parameter (SP A1), Stress strain index (SSI) and Corvis biomechanical index (CBI) } in keratoconic corneas before and after 3 and 6 months CXL using Corvis ST. * Measurement of demarcation line depth using anterior segment OCT and correlate between corneal stiffness following CXL and demarcation line depth.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: December 16, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 16, 2021

Record last verified: 2021-12