Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Conditions
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Aphakia, Cataract

Intervention / Treatment
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* Device: FY-60AD
* Device: NHT15, NHT30, & NHT53


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NHT15<br>Aspheric Toric Intraocular Lens Models NHT15 | Device: NHT15, NHT30, & NHT53<br>* Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.<br>|
| Active Comparator: FY-60AD<br>Aspheric Non-toric Intraocular Lens: Model FY-60AD | Device: FY-60AD<br>* Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.<br>|
| Experimental: NHT30<br>Aspheric Toric Intraocular Lens Model NHT30 | Device: NHT15, NHT30, & NHT53<br>* Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.<br>|
| Experimental: NHT53<br>Aspheric Toric Intraocular Lens Models NHT53 | Device: NHT15, NHT30, & NHT53<br>* Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent reduction of absolute cylinder |  | up to 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens rotation or misalignment and patient satisfaction |  | up to 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular lens, IOL, cataract, refractive astigmatism, Aspheric, Toric, Hoya, Surgical, Optics, visual acuity