Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing
This study is currently recruiting participants.
Verified June 2011 by Lenstec Incorporated
Sponsor:
Lenstec Incorporated
Information provided by:
Lenstec Incorporated
ClinicalTrials.gov Identifier:
NCT01249144
First received: November 24, 2010
Last updated: June 27, 2011
Last verified: June 2011
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Purpose
This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: Intraocular Lens (IOL) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery |
Resource links provided by NLM:
Further study details as provided by Lenstec Incorporated:
Primary Outcome Measures:
- Target versus Achieved Refraction [ Time Frame: 3 Months Postoperative ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Uncorrected Visual Acuity [ Time Frame: 3 Months Postoperative ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Tecnis Z9002 Intraocular Lens (IOL) |
Device: Intraocular Lens (IOL)
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.
|
| Active Comparator: Softec HD Intraocular Lens (IOL) |
Device: Intraocular Lens (IOL)
Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- operable cataracts in both eyes
- require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
- </=1 diopter (D) of regular astigmatism in both eyes
Exclusion Criteria:
- Intraocular surgery or laser treatment prior to cataract surgery
- Severe dry eye
- Presence of ocular infection
- Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
- Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
- History of retinal detachment
- Corneal decompensation
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249144
Contacts
| Contact: J. Pitzer Gills, III, MD | 800.282.9905 |
Locations
| United States, Florida | |
| St. Luke's Cataract & Laser Institute | Recruiting |
| Tarpon Springs, Florida, United States, 34689 | |
| Principal Investigator: J. Pitzer Gills, III, MD | |
Sponsors and Collaborators
Lenstec Incorporated
Investigators
| Principal Investigator: | J. Pitzer Gills, III, MD | St. Luke's Cataract and Laser Institute |
More Information
No publications provided
| Responsible Party: | Erin Hayes / Director of Clinical Research, Lenstec, Inc. |
| ClinicalTrials.gov Identifier: | NCT01249144 History of Changes |
| Other Study ID Numbers: | LTHD-10-05 |
| Study First Received: | November 24, 2010 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Lenstec Incorporated:
|
Intraocular Lens (IOL) Quarter Diopter Biaspheric |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013