To demonstrate that FS laser aided keratoplasty for KC is superior to MALK.
ID
Source
Brief title
Condition
- Ocular structural change, deposit and degeneration NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Astigmatism.
Secondary outcome
Visus (BSCVA, UCVA, BclCVA).
Endothelial cell density.
Number of eyes that need a hard contactlens to achieve a VA > 0.5 at 1 year.
Graft survival.
RMS of Zernike polynomials of high order aberrations.
Contrast sensitivity and stray light.
Quality of vision questionnaire.
OT time and costs.
Background summary
With severe keratoconus (KC), refractive abnormalities become non-correctable
and, eventually, a corneal transplant is the only treatment option left to
restore vision. Continuing technological developments suggest that VA outcome
and rehabilitation rate can be further improved. Surgical outcome, i.e.
postoperative astigmatism, of femtosecond (FS) laser assisted mushroom
keratoplasty and microkeratome assisted lamellar keratoplasty (MALK) will be
compared.
Study objective
To demonstrate that FS laser aided keratoplasty for KC is superior to MALK.
Study design
Randomized, comparative.
Intervention
FS laser aided keratoplasty or MALK.
Study burden and risks
The outcome of FS laser aided mushroom keratoplasty is expected to be better
but the risk of endothelial complications is supposed to be higher. Assessments
for this study are non-invasive and inconvenience is negligible. Extra time
required for these measurements is approximately 1 hour per visit (5X).
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years.
Informed consent.
Severe KC needing keratoplasty.
Exclusion criteria
Unable to attend the FU visits.
Mental retardation, including trisomy 21.
Severe progressive glaucoma.
History of retinal surgery, glaucoma surgery or age related macular disease.
Severe nystagmus.
History of surgical correction of astigmatism.
History of corneal or refractive surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51078.078.14 |
| OMON | NL-OMON22202 |