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OpenTrials
Completed

NCT Number: NCT01544777

Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study

To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.

Completed

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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Senile cataract
  • Patient identified as a candidate for cataract surgery and IOL implantation
  • Willing to sign informed consent document approved by the Ethical Committee
  • Willing to complete all required tests and exams per this protocol

Exclusion criteria

  • Amblyopia
  • History or evidence of any ocular disease that may affect visual acuity
  • Previous ocular surgery, including refraction surgery
  • Ocular anomalies (e.g. microphthalmos, kerataconous)
  • Subjects with greater than 1.0 D of corneal astigmatism
  • Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt

Treatment and study plan

Study IOL

Device

Aspheric IOL for correction of aphakia

Other names: Hoya iSert 751 IOL

Hoya iSert 751

Device

Model 751 in one eye, standard IOL in other eye

Other names: Hoya iSert Model 751

Negatively aspheric IOL

Device

Negatively aspheric IOL in both eyes

Other names: Hoya iSert model 251 or equivalent

Primary outcomes

  1. Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

Hoya Surgical Optics, Inc.

Industry

Registry information

Official study title

Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study

Acronym: 751

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 6, 2012
Registry last updated
Mar 25, 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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