Clinical Analysis of Two Toric Intraocular Lenses

NCT ID: NCT03371576

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-01

Study Completion Date

2017-09-01

Brief Summary

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Purpose: Comparison of two torical intraocular lenses with differents haptic design in patients with cataract.

Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after surgery visual acuity, rotation stability and astigmatism correction were evaluated.

Detailed Description

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Conditions

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Cataract IOL

Keywords

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toric IOL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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2 different torical intraocular lenses

intraocular lenses

Intervention Type DEVICE

Interventions

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intraocular lenses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age related cataract on both eyes
* Corneal astigmatism 1,0- 4,0 D
* Potential postoperative visus 1,0
* No other ocular pathology as cataract
* Age 18 - 80
* Written informed consent to surgery and participation in the study

Exclusion Criteria

* Pregnancy, breastfeeding
* Amblyopy, diabetic retinopathy, uveitis or other relevant ophthalmologic diseases
* Optical media disturbances due to: corneal and vitreal opacity, PEX
* Irregular astigmatism measured with corneal topography (Visante-omni), keratoconus
* ≥ 10 degrees difference between the axis of keratometry measurement of the IOL Master and the simulated K reading of the corneal topograph (Visante-omni)
* Trauma, ocular surgery performed within 6 months
* Traumatic cataract
* Potential postoperative visus under 1,0
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Hietzing

OTHER

Sponsor Role lead

Responsible Party

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Michael Lasta

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Mihaltz K, Lasta M, Burgmuller M, Vecsei-Marlovits PV, Weingessel B. Comparison of Two Toric IOLs with Different Haptic Design: Optical Quality after 1 Year. J Ophthalmol. 2018 Feb 11;2018:4064369. doi: 10.1155/2018/4064369. eCollection 2018.

Reference Type DERIVED
PMID: 29607216 (View on PubMed)

Other Identifiers

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HHietzing

Identifier Type: -

Identifier Source: org_study_id