Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
This study has been withdrawn prior to enrollment.
(Enrollment not initiated for study.)
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00760058
First received: September 24, 2008
Last updated: March 3, 2010
Last verified: March 2010
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Purpose
The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: AcrySof® IQ IOL Device: Tecnis® Aspheric intraocular lens Device: Akreos® MI60 intraocular lens |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Contrast sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
AcrySof® IQ intraocular lens
|
Device: AcrySof® IQ IOL
Replacement of natural crystalline lens in cataract surgery
|
|
Active Comparator: 2
Tecnis® Aspheric intraocular lens
|
Device: Tecnis® Aspheric intraocular lens
Replacement of natural crystalline lens in cataract surgery
|
|
Active Comparator: 3
Akreos® MI60 intraocular lens
|
Device: Akreos® MI60 intraocular lens
Replacement of natural crystalline lens in cataract surgery
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects, aged 50 and over.
- Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
- Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
- Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
- Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.
Exclusion Criteria:
- Subjects who have previously had corneal surgery.
- Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology
- Subjects with corneal pathology.
- Subjects with astigmatism of greater than 1D.
- Subjects diagnosed with glaucoma.
- Subjects diagnosed with diabetes.
- Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
- Subjects with a know history of poor compliance
- Subjects with planned adjunctive surgery
Contacts and Locations More Information
No publications provided
| Responsible Party: | Robert Kitchen, Director of Scientific Affairs, Alcon Laboratories (Australia) Pty Ltd |
| ClinicalTrials.gov Identifier: | NCT00760058 History of Changes |
| Other Study ID Numbers: | AUS-06-02 |
| Study First Received: | September 24, 2008 |
| Last Updated: | March 3, 2010 |
| Health Authority: | Australia:Health Research Ethics Committee |
Keywords provided by Alcon Research:
|
cataract, intraocular lens |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013