Keratoconus Clinical Trial
Official title:
Intacs for Keratoconus
To study the effects Intacs intracorneal ring segments(Addition Technology, Inc) insertion in the treatment of keratoconus
The purpose of this evaluation is to study the effects of implanting INTACS inserts,
identical to those commercially available to correct myopia, into the corneal stroma of
patients with keratoconus (mild to moderate) and having a clear cornea. The principle of the
procedure is to flatten the cornea deformed by keratoconus. One or two segments of the same
or a different thickness will be selected to reduce the asymmetric astigmatism responsible
for the patient impaired visual acuity.
The surgical technique is based on locating the INTACS inserts on the flattest axis of the
refractive error, making the incision on the steepest axis, using 150 degree arc length
inserts with different sizes (0.250, 0.300, 0.350, 0.400 & 0.450 mm) according to a nomogram
designed for this technique using the INTACS Instrumentation (10-Step Prolate System
instruments).
The corneal lamellar channel creation may be performed using the INTACS instrumentation or
using the Femtosecond laser (Femtec 20/10 laser[Femtec,Heidelberg Germany])
Primary Assessment Criteria
- Evaluation of the safety of the device for the treatment of patients with keratoconus
(mild to moderate)
- Maintenance of best corrected visual acuity (BCVA)
- Improvement in uncorrected visual acuity (UCVA)
- Reduction in manifest refraction spherical equivalent
- Reduction in asymmetric astigmatism
Secondary Assessment Criteria
- Evaluation of the effect of INTACS inserts placement for treatment of corneal ectasia
- Determination of patient satisfaction following the INTACS inserts procedure Patients
meeting the eligibility criteria are required to sign a Patient Informed Consent Form
prior to study participation.
A thorough examination is perform to evaluate the following:
- Manifest refraction results - Uncorrected visual acuity (UCVA) and best corrected
visual acuity (BCVA)
- Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected
visual acuity (BCVA)
- Corneal topography
- Pachymetry
- Step axis location
- Location of incision placement
- Subjective feedback about quality of vision (Excellent, Good, Fair and Poor)
Post-operative Assessment(at 1 day, 1 week, 1 month and 3 months postop)
- Uncorrected visual acuity (UCVA) and best corrected visual acuity with manifest
refraction(BCVA) at designated time interval
- Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected
visual acuity (BCVA) at designated time interval
- Corneal topography at designated time interval
- Pachymetry at designated time interval
- Subjective visual outcome ratings over time (Excellent, Good, Fair and Poor)
- Report adverse events
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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