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A Randomized, Comparative Trial of Two Mushroom Keratoplasty Techniques in Keratoconus Patients. Femtosecond Laser Aided True Mushroom Keratoplasy versus Microkeratome Assisted Lamellar Keratoplasty (MALK).


- candidate number22287
- NTR NumberNTR5199
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2015
- Secondary IDsNL51078.078.14 OZR 2014-19
- Public TitleA Randomized, Comparative Trial of Two Mushroom Keratoplasty Techniques in Keratoconus Patients. Femtosecond Laser Aided True Mushroom Keratoplasy versus Microkeratome Assisted Lamellar Keratoplasty (MALK).
- Scientific TitleA Randomized, Comparative Trial of Two Mushroom Keratoplasty Techniques in Keratoconus Patients. Femtosecond Laser Aided True Mushroom Keratoplasy versus Microkeratome Assisted Lamellar Keratoplasty (MALK).
- ACRONYM
- hypothesisFemtosecond (FS) laser aided keratoplasty for KC is superior to MALK.
- Healt Condition(s) or Problem(s) studiedkeratoplasty
- Inclusion criteria- Age ¡İ 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate31-dec-2017
- Target number of participants38
- InterventionsFemtosecond laser aided keratoplasty; MALK
- Primary outcomeAstigmatism
- 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.
- Timepointsbaseline, 1, 3, 6, 12 month
- Trial web site
- statusstopped
- CONTACT FOR PUBLIC QUERIES J. Rooij, van
- CONTACT for SCIENTIFIC QUERIES J. Rooij, van
- Sponsor/Initiator The Rotterdam Eye Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsNot applicable
- Brief summaryRationale: 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).
- Main changes (audit trail)
- RECORD8-jun-2015 - 22-okt-2017


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