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NCT02883868 Clinical Trial

Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency?

Progressive Keratoconus Clinical Trial

— STROMA-CROSS  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02883868
Other study ID # 2015-09Obs-CHRMT
Secondary ID
Status Completed
Phase N/A
First received August 25, 2016
Last updated September 14, 2016
Start date October 2015
Est. completion date March 2016

Study information
Verified date August 2016
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

To assess the association between stromal demarcation line after collagen crosslinking (CXL) for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical outcomes of CXL

Description:

All consecutive patients treated with CXL between March 2014 and March 2015 were included. They all underwent the same procedure: accelerated-CXL protocol (10 minutes UVA irradiation with 9 mW/cm2 intensity), irradiation device (IROC UV-X™ 2000, Medeuronet). One month after the procedure, AS-OCT examination was performed in all patients (RS-3000, NIDEK). The visibility of the stromal demarcation line was scored (0: not visible line; 1: visible line, but measurement not clearly defined; 2: clearly visible line) and its depth was measured centrally at anytime it was possible. Changes in best corrected visual acuity (BCVA), spherical equivalent (SE), Kmax and thinnest pachymetry, were studied preoperatively and at 6 months

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date March 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients treated with CXL

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome
Type Measure Description Time frame Safety issue
Primary visibility of the stromal demarcation line month 1 No
See also
  Status Clinical Trial Phase
Recruiting NCT02721628 - Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus 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
Recruiting NCT04045626 - Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns N/A
Completed NCT03442751 - Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus Phase 3
Completed NCT01411384 - Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus N/A
Withdrawn NCT00679666 - Corneal Crosslinking in Keratoconus and Corneal Ectasia Phase 2/Phase 3
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