Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-06-30

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.

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Detailed Description

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Conditions

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Aphakia Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NHT15

Aspheric Toric Intraocular Lens Models NHT15

Group Type EXPERIMENTAL

NHT15, NHT30, & NHT53

Intervention Type DEVICE

Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.

FY-60AD

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

Group Type ACTIVE_COMPARATOR

FY-60AD

Intervention Type DEVICE

Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.

NHT30

Aspheric Toric Intraocular Lens Model NHT30

Group Type EXPERIMENTAL

NHT15, NHT30, & NHT53

Intervention Type DEVICE

Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.

NHT53

Aspheric Toric Intraocular Lens Models NHT53

Group Type EXPERIMENTAL

NHT15, NHT30, & NHT53

Intervention Type DEVICE

Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.

Interventions

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FY-60AD

Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.

Intervention Type DEVICE

NHT15, NHT30, & NHT53

Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.

Intervention Type DEVICE

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No