Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study (751)

Hoya

Status: Completed

Conditions: Cataract; Aphakia

Treatments: Device: Negatively aspheric IOL; Device: Study IOL; Device: Hoya iSert 751

Study type: Interventional

Funder types: Industry

Identifiers

NCT01544777

DOF-1

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Both Eyes

Experimental group

Description:

Model 751 IOL implanted in both eyes.

Treatment:

Device: Study IOL

Single eye

Experimental group

Description:

Model 751 IOL in one eye

Treatment:

Device: Hoya iSert 751

Control

Active Comparator group

Description:

Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent

Treatment:

Device: Negatively aspheric IOL