Aphakia, Cataract
Conditions
Keywords
Aphakia, Cataract
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.
Interventions
DEVICEStudy IOL
Aspheric IOL for correction of aphakia
DEVICEHoya iSert 751
Model 751 in one eye, standard IOL in other eye
DEVICENegatively aspheric IOL
Negatively aspheric IOL in both eyes
Sponsors
Hoya Surgical Optics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near | Up to 3 months |
Countries
Australia
Outcome results
None listed