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NCT04045626 Clinical Trial

Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns

Progressive Keratoconus Clinical Trial

Official title:
Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04045626
Other study ID # N28
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date March 2020

Study information
Verified date August 2019
Source Kasr El Aini Hospital
Contact Sarah Azzam, MD
Phone +201227425601
Email sarahazzam@ymail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients

Description:

Anterior segment optical coherence tomography "OCT" will be performed to evaluate the corneal stroma for the presence of demarcation line 1 month postoperatively by an independent observer unware of purpose of study

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- progressive keratoconus stage 1-2

Exclusion Criteria:

- any concomitant ocular disease

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• corneal cross-linking
Riboflavin is instilled over cornea followed by Ultraviolet-A irradiation

Locations
Country Name City State
Egypt Kasr Al Ainy teaching hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary evaluation of depth of demarcation line Anterior segment optical coherence tomography "AS-OCT" is used to measure depth of demarcation line 1 month postoperative
See also
  Status Clinical Trial Phase
Recruiting NCT02721628 - Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus N/A
Completed NCT02883868 - Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency? N/A
Active, not recruiting NCT04427956 - Corneal Crosslinking Treatment Study Phase 4
Terminated NCT01868620 - Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus. N/A
Recruiting NCT05314738 - Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus Phase 1/Phase 2
Not yet recruiting NCT06450470 - Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus Phase 3
Completed NCT02117999 - Transepithelial Corneal Cross-linking Using Iontophoresis N/A
Completed NCT01485211 - Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin Phase 4
Completed NCT04504578 - Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas N/A
Completed NCT00647699 - Corneal Collagen Cross-linking for Progressive Keratoconus Phase 3
Completed NCT00567671 - Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia Phase 2/Phase 3
Recruiting NCT00815256 - Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus Phase 3
Completed NCT03442751 - Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus Phase 3
Withdrawn NCT00679666 - Corneal Crosslinking in Keratoconus and Corneal Ectasia Phase 2/Phase 3
Completed NCT01411384 - Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus N/A
Not yet recruiting NCT00925327 - Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus Phase 2