Cataract Clinical Trial
Official title:
Comparison of Two Toric IOL´s With Different Haptic Design: Optical Quality After 1 Year
| Verified date | December 2017 |
| Source | Hospital Hietzing |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | September 1, 2017 |
| Est. primary completion date | August 1, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Hietzing |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | uncorrected visual acuity | visual acuity in logMARon an ETDRS Chart | 1 year |
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