Clinical Analysis of Two Toric Intraocular Lenses
Comparison of Two Toric IOL´s With Different Haptic Design: Optical Quality After 1 Year
1 other identifier
observational
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2012
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 23, 2017
CompletedFirst Posted
Study publicly available on registry
December 13, 2017
CompletedDecember 13, 2017
December 1, 2017
3.2 years
November 23, 2017
December 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
uncorrected visual acuity
visual acuity in logMARon an ETDRS Chart
1 year
Study Arms (1)
2 different torical intraocular lenses
Interventions
Eligibility Criteria
Patients with cataract on both eyes.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29607216DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 23, 2017
First Posted
December 13, 2017
Study Start
June 1, 2012
Primary Completion
August 1, 2015
Study Completion
September 1, 2017
Last Updated
December 13, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share