The main objective is to establish whether a relationship can be demonstrated between the amount of light scattered at the post-operative corneal interface on the one hand and visual acuity and contrast sensitivity on the other. In addition, changes…
ID
Source
Brief title
Condition
- Ocular structural change, deposit and degeneration NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantification of possible relationship between corneal reflectivity (confocal
microscopy) and:
- visual acuity (logMAR)
- contrast sensitivity (Pelli Robson chart)
- keratoplastic technique
Secondary outcome
Quantification of possible relationship between corneal reflectivity and:
- scatter measured by Oculus C-quant
- pachymetry (3 methods)
Quantification of:
- endothelial cell density
- quality of life
Background summary
The outcome of recently developed lamellar techniques of keratoplasty strongly
depends on the optical properties of the donor-host interface. Thus far, no
criteria are set for the optical quality of the post-operative cornea.
Preferably, such an evaluation should be accurate, reliable and user-friendly
at the same time. In vivo confocal microscopy appears to be meet these
requirements as a tool for inspection of the scatter properties of the corneal
donor-host interface.
Study objective
The main objective is to establish whether a relationship can be demonstrated
between the amount of light scattered at the post-operative corneal interface
on the one hand and visual acuity and contrast sensitivity on the other. In
addition, changes over time will be explored for the parameters under
examination.
Study design
Prospective, non-randomized.
Study burden and risks
Patients due for keratoplasty are standardly scheduled for one pre-op and six
post-op visits. Study-related measurements will be performed during these
visits and will take approximately 50 minutes extra time per session.
Participants of this study do not benefit from the results of this study. Risks
are negligible.
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Schiedamse Vest 180
3011 BH Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Group 1, PKP:
- BCVA >= 0.4 (logMAR)
- not eligible for ALTK, DALK, PLK;Group 2, ALTK:
- BCVA >= 0.4 (logMAR);Group 3, DALK:
- BCVA >= 0.4 (logMAR)
- keratoconus without hydrops or Descemet*s rupture
- stromal opacities not reaching Descemet*s membrane
- no concommitant endothelial disease;Group 4, PLK:
- BCVA >= 0.4 (logMAR)
- endothelial dysfunction caused by pseudophakic or aphakic edema
- (Fuch*s) endothelial dystrophy
Exclusion criteria
Group 1, PKP:
- mental retardation
- previous corneal surgery ;Group 2, ALTK:
- mental retardation
- history of (penetrating) keratoplasty
- HLA-typed keratoplasty;Group 3, DALK:
- mental retardation
- history of (penetrating) keratoplasty
- HLA-typed keratoplasty;Group 4, PLK:
- mental retardation
- history of (penetrating) keratoplasty
- HLA-typed keratoplasty
- severe scarring of anterior stroma
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14835.078.06 |