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Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency? (STROMA-CROSS)

C

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Conditions

Progressive Keratoconus

Study type

Observational

Funder types

Other

Identifiers

NCT02883868
2015-09Obs-CHRMT

Details and patient eligibility

About

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

Full 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

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients treated with CXL

Exclusion criteria

Trial design

36 participants in 1 patient group

patients treated with CXL

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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