Aphakia, Cataract
Conditions
Keywords
intraocular lens, IOL, cataract, refractive astigmatism, Aspheric, Toric, Hoya, Surgical, Optics, visual acuity
Brief summary
The purpose of this multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism.
Interventions
DEVICEFY-60AD
Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.
DEVICENHT15, NHT30, & NHT53
Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
Sponsors
Hoya Surgical Optics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated * Have at least one eye that meets the ranges of pre-operative corneal cylinder as specified by this study's guidelines, i.e. corneal cylinder of at least 1.0 D (after accounting for changes in corneal cylinder due to the incision) * Have potential Best Corrected Visual Acuity of 20/30 or better after implantation of a study lens * Have clear intraocular media other than cataract * Have preoperative Best Corrected Visual Acuity equal to 20/40 or worse, with or without a glare source
Exclusion criteria
* Have atonic pupils or physiologically small pupils in either eye (unable to dilate to at least 4 mm) * Have irregular astigmatism in the operative eye, or refractive cylinder resulting only from lenticular astigmatism in the operative eye * Have corneal pathology potentially affecting corneal topography, or other corneal abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period * Have undergone previous refractive corneal surgery in the operative eye * Have been diagnosed with any degenerative retinal disorders (e.g. soft drusen, macular degeneration or other progressive retinal disorders) in the operative eye that are predicted to cause future visual acuity losses to a level of 20/30 or worse during the postoperative follow-up time requirements of this study Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percent reduction of absolute cylinder | up to 14 months |
Secondary
| Measure | Time frame |
|---|---|
| Lens rotation or misalignment and patient satisfaction | up to 14 months |
Countries
United States
Outcome results
None listed