Status:
TERMINATED
PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Dr. F.P. Fischer-stichting, Utrecht, The Netherlands
Conditions:
Keratoconus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rationale: Keratoconus is a progressive, non-inflammatory corneal disease in which irregular refractive properties of the cornea result in loss of visual acuity. Treatment is aimed at improving visio...
Detailed Description
Background: Keratoconus is a progressive, non-inflammatory corneal disease in which irregular refractive properties of the cornea result in loss of visual acuity. Keratoconus usually arise in adolesc...
Eligibility Criteria
Inclusion
- age equal or above 18 years
- keratoconus as defined and classified by
- presence of corneal thinning and protrusion on slit-lamp examination
- topographic criteria according to KISA% index (\>100%)
- mean corneal curvature map
- decreased best corrected visual acuity due to corneal scarring or contact lens intolerance
Exclusion
- prior corneal surgery, cross linking, refractive surgery or other treatment modalities
- (localized) corneal thickness \< 200 µm
- associated corneal endothelial disease on specular microscopy as defined by:
- \<1500 endothelial cells per mm2
- polymegathism \> 0.3
- pleomorphism \< 0.6 (all are measurements of endothelial dysfunction)
- gross ophthalmic pathology surpassing keratoconus as cause of decreased visual acuity
- keratoconus-like disease (keratoglobus, pellucid marginal degeneration)
- associated corneal anomalies (microcornea, macrocornea, buphthalmos, Peters syndrome, ICE-syndrome etc.)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01145937
Start Date
March 1 2011
End Date
May 1 2015
Last Update
December 3 2015
Active Locations (5)
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1
Amphia Ziekenhuis
Breda, Netherlands, 4819 EV
2
Westfries Gasthuis
Hoorn, Netherlands, 1620 AR
3
UMCN St. Radboud
Nijmegen, Netherlands, 6500HB
4
Rotterdam Eye Hospital
Rotterdam, Netherlands, 3000 LM