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OpenTrials
Completed

NCT Number: NCT01268540

Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

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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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Hoya Surgical Optics, Inc. for Trial Locations, Chino Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FY-60AD

Device

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

NHT15, NHT30, & NHT53

Device

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

Primary outcomes

  1. percent reduction of absolute cylinder

    Time frame: up to 14 months

Secondary outcomes

  1. Lens rotation or misalignment and patient satisfaction

    Time frame: up to 14 months

Sponsors and collaborators

Lead sponsor

Hoya Surgical Optics, Inc.

Industry

Registry information

Acronym: COAST

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 31, 2010
Registry last updated
Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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