Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses (COAST)
This study is currently recruiting participants.
Verified February 2013 by Hoya Surgical Optics, Inc.
Sponsor:
Hoya Surgical Optics, Inc.
Information provided by (Responsible Party):
Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier:
NCT01268540
First received: December 29, 2010
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
The purpose of this multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism.
| Condition | Intervention |
|---|---|
|
Aphakia Cataract |
Device: FY-60AD Device: NHT15, NHT30, & NHT53 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses |
Resource links provided by NLM:
Further study details as provided by Hoya Surgical Optics, Inc.:
Primary Outcome Measures:
- percent reduction of absolute cylinder [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Lens rotation or misalignment and patient satisfaction [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 235 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NHT15
Aspheric Toric Intraocular Lens Models NHT15
|
Device: NHT15, NHT30, & NHT53
Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
|
|
Active Comparator: FY-60AD
Aspheric Non-toric Intraocular Lens: Model FY-60AD
|
Device: FY-60AD
Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.
|
|
Experimental: NHT30
Aspheric Toric Intraocular Lens Model NHT30
|
Device: NHT15, NHT30, & NHT53
Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
|
|
Experimental: NHT53
Aspheric Toric Intraocular Lens Models NHT53
|
Device: NHT15, NHT30, & NHT53
Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
- Have at least one eye that meets the ranges of pre-operative corneal cylinder as specified by this study's guidelines, i.e. corneal cylinder of at least 1.0 D (after accounting for changes in corneal cylinder due to the incision)
- Have potential Best Corrected Visual Acuity of 20/30 or better after implantation of a study lens
- Have clear intraocular media other than cataract
- Have preoperative Best Corrected Visual Acuity equal to 20/40 or worse, with or without a glare source
Exclusion Criteria:
- Have atonic pupils or physiologically small pupils in either eye (unable to dilate to at least 4 mm)
- Have irregular astigmatism in the operative eye, or refractive cylinder resulting only from lenticular astigmatism in the operative eye
- Have corneal pathology potentially affecting corneal topography, or other corneal abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- Have undergone previous refractive corneal surgery in the operative eye
- Have been diagnosed with any degenerative retinal disorders (e.g. soft drusen, macular degeneration or other progressive retinal disorders) in the operative eye that are predicted to cause future visual acuity losses to a level of 20/30 or worse during the postoperative follow-up time requirements of this study
Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268540
Contacts
| Contact: Hoya Surgical Optics, Inc. | 1-866-750-5870 |
Locations
| United States, California | |
| Contact Hoya Surgical Optics, Inc. for Trial Locations | Recruiting |
| Chino Hills, California, United States, 91709 | |
| Shepard Eye Center | Recruiting |
| Santa Maria, California, United States, 93454 | |
| United States, Florida | |
| Mid-Florida Eye Center | Recruiting |
| Mt. Dora, Florida, United States, 32757 | |
| United States, Michigan | |
| Grosinger, Spigelman & Grey, | Recruiting |
| Bloomfield Hills, Michigan, United States, 48302 | |
| United States, Missouri | |
| Silverstein Eye Conters | Recruiting |
| Dansas City, Missouri, United States, 64133 | |
| United States, Ohio | |
| Cleveland Eye Clinic | Recruiting |
| Brecksville, Ohio, United States, 44141 | |
Sponsors and Collaborators
Hoya Surgical Optics, Inc.
Investigators
| Study Director: | James Wartman | Hoya Surgical Optics, Inc. |
More Information
No publications provided
| Responsible Party: | Hoya Surgical Optics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01268540 History of Changes |
| Other Study ID Numbers: | 2010-T240 |
| Study First Received: | December 29, 2010 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hoya Surgical Optics, Inc.:
|
intraocular lens IOL cataract refractive astigmatism Aspheric |
Toric Hoya Surgical Optics visual acuity |
Additional relevant MeSH terms:
|
Aphakia Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 13, 2013