Astigmatism, Cataract, Cornea
Conditions
Keywords
multifocal, IOL, astigmatism, incision, cataract surgery, implant
Brief summary
The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery.
Detailed description
This is a randomized controlled trial with intra-patient comparison, 60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 2.50 D (doctrine) took part in the trial. The trial assessed the efficacy of multifocal IOL (intraocular lens) with corneal pre-existing astigmatism and compare the outcomes of a multifocal toric IOL or a standard multifocal IOL combined with limbal relaxing incisions.
Interventions
DEVICEToric multifocal IOL
Implant of Multifocal toric intraocular lens only
DEVICENon-toric multifocal IOL
Implant of non-toric multifocal lens plus incisional surgery
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bilateral cataract and be planning to have both eyes operated on. * Age 21 and older * Have cataracts that allow IOL master biometry * Regular corneal astigmatism 1.00 up to 2.50 D * Difference of corneal astigmatism in both eyes to be equal to or less than 0.75D * written informed consent to surgery and participation in the study * Speak English
Exclusion criteria
* Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome) * Irregular corneal astigmatism on Pentacam topography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite scoring of unaided distance and near vision (monocularly) | 3 months | Measurement of uncorrected and best corrected visual acuity will be done using a back-lit EDTRS chart placed at 4m. Near and distance unaided and corrected visual acuity will be measured, measuring reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk) and contrast vision under photopic and mesopic conditions (Pelli-Robson Chart). Reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk). The Salzburg Reading Desk (SRD) is the prototype of a reading chart that measures reading speed and reading distance. Contrast and light conditions are preset and reading distance (+/- 0.2 cm), reading speed and their changes during the examination are measured. This ensures an objective evaluation of measurements under the same conditions at every follow-up. |
| Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon) | 3 months | Measurement of residual astigmatism will be derived from autorefraction with an autorefractor (Topcon) with mean reading of 5 consecutive measurements in IOL mode, a subjective refraction by an optometrist using trial lenses and the cross cylinder method. All these measurements are non-invasive, non-contact and readily used in daily clinical practice. |
Outcome results
None listed