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

Not Applicable

Completed

• Conditions: Aphakia; Cataract
• Interventions: Device: Hoya iSert 751; Device: Study IOL; Device: Negatively aspheric IOL

• 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

Arm && Interventions

Group	Intervention	Description
Single eye	Hoya iSert 751	Model 751 IOL in one eye
Both Eyes	Study IOL	Model 751 IOL implanted in both eyes.
Control	Negatively aspheric IOL	Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent

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