COAST: Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Sponsor

Hoya Surgical Optics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01268540

Collaborator

(none)

235

Enrollment

Locations

Arms

Duration (Months)

39.2

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Aphakia Cataract	Device: FY-60AD Device: NHT15, NHT30, & NHT53	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

235 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

percent reduction of absolute cylinder [up to 14 months]

Secondary Outcome Measures

Lens rotation or misalignment and patient satisfaction [up to 14 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Contact Hoya Surgical Optics, Inc. for Trial Locations	Chino Hills	California	United States	91709
2	Shepard Eye Center	Santa Maria	California	United States	93454
3	Mid-Florida Eye Center	Mt. Dora	Florida	United States	32757
4	Grosinger, Spigelman & Grey,	Bloomfield Hills	Michigan	United States	48302
5	Silverstein Eye Conters	Dansas City	Missouri	United States	64133
6	Cleveland Eye Clinic	Brecksville	Ohio	United States	44141