Partial endothelial trepanation in addition to deep anterior lamellar keratoplasty in keratoconus patients. A randomized clinical trial.
Completed
- Conditions
- corneal ectasia.keratoconus1001592010010463
- Registration Number
- NL-OMON36229
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
- age equal or above 18 years
- keratoconus as defined by
presence of corneal thinning and protrusion on slit-lamp examination
topographic criteria according to KISA% index
- decreased best corrected visual acuity due to corneal scarring or contact lens intolerance
Exclusion Criteria
- prior corneal surgery, cross linking, refractive surgery or other treatment modalities
- associated corneal endothelial disease
- gross ophthalmic pathology surpassing keratoconus as couse of decreased visual acuity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is:<br /><br><br /><br>* peroperative complications and conversion ratios;</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study objectives are:<br /><br><br /><br>* best corrected visual acuity one year post op;<br /><br>* manifest refraction one year post op;<br /><br>* self-rated improvement questionnaire;<br /><br>* graft rejection rate;<br /><br>* corneal endothelial function one year post op.</p><br>