Refractive Accuracy and Rotational stability with an Aspheric Toric Intraocular Lens With and Without Implantation of a Capsular Tension Ring - a randomized two parallel arms clinical trial

Phase 4

• Conditions: H25.0; H52.2; Senile incipient cataract; Astigmatism

• Registration Number: DRKS00015316
• Lead Sponsor: OcuNet GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-06-18
• Study Start: 2018-08-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

intended implantation of Tecnis Toric in one or both eyes - age-related cataract with regular astigmatism - requiring an IOL power between 16.0 and 26.0 D SEQ - intended and reasonable ambulant cataract surgery -age 18 and older - regular astigmatism with a corneal cylinder between 0.75 and -2.75 D - patients with a post-operative potential best-corrected visual acuity of 0.5 or better based on the estimation of the surgeon - written informed consent to surgery, participation in the study and data protection

Exclusion Criteria

- the partner eye was already recruited - relevant concomitant ophthalmic diseases (such as significant cornea guttata, significant corneal scar/opacity, glaucoma, NPDR stage II or II, PDR, pseudoexfoliation, trauma, AMD and other co-morbidity that could result in an outcome worse than UCVA 0.5 or that might affect capsular bag stability) - history of relevant previous ocular surgery (such as corneal surgery, glaucoma surgery, vitreoretinal surgery, other surgery) which might result in an outcome worse than UCVA 0.5 or that might affect capsular stability - expected residual cylinder = 0,5 dpt - Patient participates in other clinical trials

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
maximum absolute difference of 0.5 D between preoperatively calculated and achieved cylinder, emerged three months after implantation or at time of a revision [yes / no]

Secondary Outcome Measures

Name	Time	Method
absolute total IOL rotation of 5° or less immediately after implantation (horizontal position) versus three months afterwards or at time of a revision [yes / no]