Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus Limbal Relaxing Incision (LRI) Patients
This study has been withdrawn prior to enrollment.
(Management Decision)
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00929747
First received: June 25, 2009
Last updated: April 10, 2012
Last verified: October 2009
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Purpose
A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataracts |
Device: Toric Procedure: Limbal Relaxing Incision |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Corneal aberration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | June 2009 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Toric IOL
AcrySof IQ Toric IOL
|
Device: Toric
Unilateral implantation of the AcrySof IQ Toric IOL
|
|
Active Comparator: Limbal Relaxing Incision
AcrySof IQ with Limbal Relaxing Incision
|
Procedure: Limbal Relaxing Incision
Unilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- operable cataracts
- good ocular health
- 0.5 D to 2.0 D of corneal astigmatism
Exclusion Criteria:
- > 2.0 D astigmatism
- irregular astigmatism
- prior or ongoing corneal disease or scarring
- history of ocular disease
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929747
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929747
Locations
| United States, Texas | |
| Alcon Call Center for Trial Locations | |
| Fort Worth, Texas, United States, 76134 | |
Sponsors and Collaborators
Alcon Research
More Information
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00929747 History of Changes |
| Other Study ID Numbers: | M08-008 |
| Study First Received: | June 25, 2009 |
| Last Updated: | April 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
Cataract Toric IOL AcrySof, LRI |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on September 28, 2016