Effectiveness and cost-effectiveness of TORIC intraocular lens implantation in patients with mild astigmatism

Effectiveness and cost-effectiveness of TORIC intraocular lens implantation in patients with mild astigmatism - the ESCRS TORIC study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54905

Enrollment

Registered

2021-05-25

Start date

2024-12-10

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

Astigmatism and cataract surgery cataract

Interventions

The intervention group will receive bilateral phacoemulsification with toric IOLs. The control group will receive bilateral phacoemulsification with non-toric monofocal IOLs. Patients and investigat

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Bilateral cataract for which uneventful phacoemulsification and IOL implantation is planned; - Predicted residual refractive astigmatism of >=0.75 to

Exclusion criteria

Exclusion criteria: - Irregular astigmatism or abnormal corneal topography; - Previous intraocular or corneal (refractive) surgery; - Hard contact lens wear; - Dilated pupillary diameter smaller than 6 mm; - Projected corrected visual acuity higher than 0.2 logMar (lower than 0.63 decimal); - Visual limiting ocular comorbidity: e.g. macular pathology, uncontrolled glaucoma; - Traumatic cataract or pseudoexfoliation; - Target refraction other than emmetropia; - Require an IOL that is not within the available power range of the manufacturer; - Pregnancy (current and planned) or lactation; - Patients participating in another drug or device investigation; - Unavailable to undergo second eye surgery within two weeks of first eye surgery; - Patients unable to consent or complete follow-up visits.

Design outcomes

Primary

Measure	Time frame
The primary study parameter is the mean UDVA of the toric IOL group after cataract operations compared to the non-toric IOL group.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints are: - Cost-effectiveness: multi-country short-term trial-based economic evaluation (TBEE) and long-term model-based economic evaluation (MBEE); - The proportion of eyes that achieve postoperative refractive astigmatism =20/25 and 20/30; - Prediction accuracy of mathematical models (that estimate the TCA) vs direct measurements of the TCA in mild PEA; - Change in PROMs from preoperative to 12 weeks postoperative; - The achieved level of reduced activity limitations after surgery; - Patient satisfaction with vision.	—

Measure

Time frame

Secondary study parameters/endpoints are: - Cost-effectiveness: multi-country short-term trial-based economic evaluation (TBEE) and long-term model-based economic evaluation (MBEE); - The proportion of eyes that achieve postoperative refractive astigmatism =20/25 and 20/30; - Prediction accuracy of mathematical models (that estimate the TCA) vs direct measurements of the TCA in mild PEA; - Change in PROMs from preoperative to 12 weeks postoperative; - The achieved level of reduced activity limitations after surgery; - Patient satisfaction with vision.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)