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Comparing the effectiveness of the Vivinex iSert IOL to the Tecnis Eyhance IOL in standard cataract surgery

Comparing the effectiveness of the Vivinex iSert IOL to the Tecnis Eyhance IOL in standard cataract surgery - Which IOL is better?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48276
Enrollment
70
Registered
2019-07-24
Start date
2019-10-02
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Cataract clouding of the lens in the eye

Interventions

Cataract surgery using phacoemulsification in both eyes during two separate operations (operation session 1: eye 1, operation session 2: eye 2), where there is a minimum of two weeks between both op

Sponsors

Elisabeth-Tweesteden ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Bilateral cataract - Expected uncomplicated cataract surgery

Exclusion criteria

Exclusion criteria: - Age 27 mm) or a difference between both eyes of > 1.5 mm * Abnormal keratometry readings * Previous refractive surgery * Myopia with posterior staphylomas - Conditions that increase the risk of corneal edema (e.g., Fuchs* endothelial dystrophy) - Factors that increase the risk of complicated surgery: * Previous ocular surgery * Previous perforating or blunt eye trauma * Eye, adnexal, or anatomical abnormalities (including pseudoexfoliation syndrome) * Lens luxation or iridodonesis * Cataract nigrans, posterior polar cataract - Sight-threatening comorbidity - Glaucoma or intraocular pressure of > 24 mmHg - Uveitis - Diabetes mellitus with diabetic retinopathy and macular edema. - Any Macular disease

Design outcomes

Primary

MeasureTime frame
The measurement of uncorrected and corrected intermediate visual acuity is the primary endpoint of this study in which the Tecnis Eyhance IOL and the Hoya Vivinex IOL are compared

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)