PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus
- Conditions
- KeratoconusEye DiseasesOther disorders of cornea
- Registration Number
- ISRCTN39068025
- Lead Sponsor
- Dr. F.P. Fischer Stichting (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1. Aged equal or above 18 years, either sex
2. Keratoconus as defined and classified by:
2.1. Presence of corneal thinning and protrusion on slit-lamp examination
2.2. Topographic criteria according to keratometry, I-S, astigmatism, and skew percentage (KISA%) index (greater than 100%)
2.3. Mean corneal curvature map
3. Decreased best corrected visual acuity due to corneal scarring or contact lens intolerance
1. Prior corneal surgery, cross linking, refractive surgery or other treatment modalities
2. (Localised) corneal thickness less than 200 µm
3. Associated corneal endothelial disease on specular microscopy as defined by:
3.1. Less than 1500 endothelial cells per mm^2
3.2. Polymegathism greater than 0.3
3.3. Pleomorphism less than 0.6 (all are measurements of endothelial dysfunction)
4. Gross ophthalmic pathology surpassing keratoconus as cause of decreased visual acuity
5. Keratoconus-like disease (keratoglobus, pellucid marginal degeneration)
6. Associated corneal anomalies (microcornea, macrocornea, buphthalmos, Peters syndrome, iridocorneal endothelial [ICE]-syndrome, etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peroperative corneal perforation
- Secondary Outcome Measures
Name Time Method <br> 1. Best corrected visual acuity one year post-operation<br> 2. Manifest refraction one year post-operation<br> 3. Contact lens use (soft/rigid/scleral) or spectacle use<br> 4. Self-rated improvement questionnaire<br> 5. Corneal endothelial function one year post-operation<br> 6. Graft rejection rate<br>