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 -

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 - - tIOL / CTR Studie

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015316

Enrollment

212

Registered

2018-08-27

Start date

2014-05-20

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

H25.0 H52.2

Interventions

Group 1: Patients with senile cataract and astimatism receiving a toric intraocular lens - WITHOUT simultaneous implantation of a capsular tension ring Group 2: Patients with senile cataract and astim

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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]	—

Countries

Germany

Contacts

Public ContactUrsula Hahn

OcuNet GmbH & Co KG

zentrale@ocunet.de0211-1793266

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026