NCT Number: NCT03371576
Clinical Analysis of Two Toric Intraocular Lenses
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.
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
uncorrected visual acuity
Time frame: 1 year
visual acuity in logMARon an ETDRS Chart
Sponsors and collaborators
Lead sponsor
Hospital Hietzing
Other
Registry information
Official study title
Comparison of Two Toric IOL´s With Different Haptic Design: Optical Quality After 1 Year
Important dates
- Study start
- 2012
- Primary completion
- 2015
- Study completion
- 2017
- First posted
- Dec 13, 2017
- Registry last updated
- Dec 13, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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