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

Hoya

Status: Completed

Conditions: Cataract; Aphakia

Treatments: Device: FY-60AD; Device: NHT15, NHT30, & NHT53

Study type: Interventional

Funder types: Industry

Identifiers

NCT01268540

2010-T240

Details and patient eligibility

About

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.

Enrollment: 235 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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235 participants in 4 patient groups

NHT15

Experimental group

Description:

Aspheric Toric Intraocular Lens Models NHT15

Treatment:

Device: NHT15, NHT30, & NHT53

FY-60AD

Active Comparator group

Description:

Aspheric Non-toric Intraocular Lens: Model FY-60AD

Treatment:

Device: FY-60AD

NHT30

Experimental group

Description:

Aspheric Toric Intraocular Lens Model NHT30

Treatment:

Device: NHT15, NHT30, & NHT53

NHT53

Experimental group

Description:

Aspheric Toric Intraocular Lens Models NHT53

Treatment:

Device: NHT15, NHT30, & NHT53