Presbyopia and astigmatism Eye Diseases Presbyopia and astigmatism
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female adults 2. Aged 21 to 80 years 3. Patient's who wish to be free of spectacles 4. Best distance corrected visual acuity projected to be better than 0.2 logMAR postoperatively (= 20/32 Snellen or 0.63 decimal) 5. Axial Length (AL) </= 25mm 6. Angle kappa<0.55mm (central optical zone of 1.11mm/2) measured with the wavefront iTrace aberrometer 7. Pupil size large enough to visualise the toric axis markings 8. Availability, willingness and sufficient cognitive awareness to comply with examination procedures 9. Signed informed consent 10. Patients suitable for Refractive lens exchange as a procedure to correct their refractive error
Exclusion criteria
Exclusion criteria: 1. Previous corneal or intraocular surgery 2. Corneal Pathology 3. uncontrolled glaucoma 4. Pseudoexfoliation syndrome 5. Retinal Detachment 6. Macular degeneration 7. Retinopathy 8. Evidence of previous uveitis 9. Amblyopia 10. Any pupil abnormalities 11. Previous ocular trauma 12. Patients with insufficient cognitive ability to undergo pre operative and post operative tests and assessments or unable to sign consent form themselves 13. Any per operative complications or deviation from the standard procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rotational stability of the implant within the eye at 6 months compared with the axial position of the implant within 24 hours after surgery will be assessed by assessing the position of the implant on the slit lamp and by using digital retroillumination photographs at baseline (24 hours post-operatively), 1 week, 1 month, 3 month and 6 month post-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective refraction is measured using subjective testing with lenses in a trial frame as at the opticians at baseline (pre-operatively), and 3 and 6 months post-operatively 2. Visual acuity at distance and for near at 40 cm both uncorrected and fully corrected and binocular acuity is measured using a Snellen chart in LogMAR units at basline, 1, 3 and 6 months post-operatively 3. Use of spectacles for distance or reading, presence of photic phenomenon and overall satisfaction with the procedure is measured using a questionnaire designed for the purpose of this study 3 and 6 months post-operatively | — |
Countries
United Kingdom