cataract corneaal astigmatism
Conditions
Interventions
There are 2 groups of subjects:
Group 1 will receive commercially available, CE marked, AcrySof ReSTOR IOL
models (SN6AD1 and SND1T2 through SND1T5)
Group 2 will receive Monofocal IOLs (commercially
Sponsors
Alcon Laboratories
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Ocular criteria must be met in both eyes; >= 21 years of age; willing and able to attend postoperative examinations as per protocol schedule; have bilateral, age-related, cataracts; have planned cataract removal via phacoemulsification with implantation of an IOL; are available to undergo second eye surgery within 6 weeks of the first eye surgery; fulfils the recommendations at the *Warnings* and *Precautions* sections of the AcrySof ReSTOR IOL and Monofocal IOL package inserts; have either no pre-operative corneal astigmatism or pre-operative regular corneal astigmatism
Exclusion criteria
Exclusion criteria: If any of the following exclusion criteria are applicable to either eye, the subject shall not be enrolled in the study; previous corneal surgery and/or reshaping; abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens; planned multiple procedures during cataract/IOL implantation surgery; planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure prior to or during the course of the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity | — |
Secondary
| Measure | Time frame |
|---|---|
| Costs of postoperative spectacle correction | — |
Countries
Netherlands
Outcome results
None listed