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

Cataract Clinical Trial

— 751  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544777
• Other study ID #: DOF-1
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: March 23, 2015
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Hoya Surgical Optics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

Device:
• Study IOL
Aspheric IOL for correction of aphakia
• Hoya iSert 751
Model 751 in one eye, standard IOL in other eye
• Negatively aspheric IOL
Negatively aspheric IOL in both eyes

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Hoya Surgical Optics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near		Up to 3 months	No