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

Not Applicable

Completed

• Conditions: Aphakia; Cataract

• Registration Number: NCT01544777
• Lead Sponsor: Hoya Surgical Optics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near	Up to 3 months

Trial Locations

Locations (1)

Sir Charles Gairdner Hospital; 🇦🇺 Nedlands, Western Australia, Australia