Trials / Completed
CompletedNCT02883868
Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency?
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 36 (actual)
- Sponsor
- Centre Hospitalier Régional Metz-Thionville · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed 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
Conditions
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2015-12-01
- Completion
- 2016-03-01
- First posted
- 2016-08-30
- Last updated
- 2016-09-15
Source: ClinicalTrials.gov record NCT02883868. Inclusion in this directory is not an endorsement.