Efficacy and cost-effectiveness of toric intraocular lenses in correcting astigmatism in cataract surgery: A Randomised Clinical Trial

Efficacy and cost-effectiveness of toric intraocular lenses in correcting astigmatism in cataract surgery: A Randomised Clinical Trial - Toric IOL Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36797

Enrollment

Registered

2009-09-28

Start date

2010-02-02

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

astigmatism cylinder

Interventions

Cataract surgery with implantation of a toric IOL (AcrySof SN6ATT) or a monofocal IOL (AcrySof SN60WF).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Bilateral cataract - Regular corneal astigmatism of minimal 1.25 diopters in both eyes - Both eyes eligible for a toric intraocular lens implantation

Exclusion criteria

Exclusion criteria: - Severe age-related macular degeneration - Glaucoma related extensive visual field loss - Extensive Diabetic macular disease - Fuchs endothelial dystrophy

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the quality of vision, measured using a patient questionnaire (the National Eye Institue 42 items Refractive Quality of LIfe, NEI RQL-42)	—

Secondary

Measure	Time frame
Secondary endpoints are: visual acuity, frequency of spectacle wear, manifest refraction, higher-order wavefront aberrations, contrast sensitivity, occurrence of complications and costs of postoperative spectacles.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)