No registrations found.
ID
Source
Health condition
KC patients indicated for keratoplasty.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Astigmatism
Secondary outcome
- Astigmatism (subjective refraction) at 6
months.
- BSCVA, UCVA, BclCVA (LogMar) at 1, 3, 6, 12
months.
- Central endothelial cell density and morphology
of the repipient pre-operatively
- Central endothelial cell density and morphology
of the grafts preoperative, 6 and 12 months.
- Number of eyes that need a hard contactlens to
achieve a VA > 0.5 at 1 year.
- Graft survival (in terms of clear grafts).
- RMS (root mean square) of Zernike polynomials
of high order aberrations of the corneal surface
(topography derived) at 1, 3, 6, 12 months.
- Contrast sensitivity (CS) and stray light at 1, 6
and 12 months.
- Quality of vision questionnaire at 1, 6 and 12
months.
- OT time and costs.
Background summary
Rationale: 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.
Objective: To demonstrate that FS laser aided keratoplasty for KC is superior to MALK.
Study design: Randomized, comparative.
Study population: KC patients indicated for keratoplasty.
Intervention: FS laser aided keratoplasty or MALK.
Main study parameters/endpoints: Astigmatism.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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).
Study objective
Femtosecond (FS) laser aided keratoplasty for KC is superior to MALK.
Study design
baseline, 1, 3, 6, 12 month
Intervention
Femtosecond laser aided keratoplasty; MALK
PO Box 70030
J. Rooij, van
Rotterdam 3000 LM
The Netherlands
+31 (0)10 4017777
PO Box 70030
J. Rooij, van
Rotterdam 3000 LM
The Netherlands
+31 (0)10 4017777
Inclusion criteria
- Age ¡Ý 18 years.
- Informed consent.
- Severe KC needing keratoplasty (i.e. high irregular astigmatism that cannot be corrected with daily wear hard contact lenses).
Exclusion criteria
- Unable to attend the FU visits.
- Mental retardation (including trisomy 21).
- Pregnancy/lactation (no pregnancy test
required).
- Severe progressive glaucoma (stable glaucoma
on topical therapy is excepted).
- History of retinal surgery, glaucoma surgery or
age related macular disease.
- Severe nystagmus.
- History of surgical correction of astigmatism
(including toric intra-ocular lens implants
and ¡®intacts¡¯).
- History of corneal or refractive surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5068 |
| NTR-old | NTR5199 |
| CCMO | NL51078.078.14 |
| OMON | NL-OMON42181 |