Clinical trial NCT01268540: Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses
Official title: Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Cataract
Keywords: intraocular lens
IOL
cataract
refractive astigmatism
Aspheric
Toric
Hoya
Surgical
Optics
visual acuity
Lead sponsor: Hoya Surgical Optics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-31
Enrollment: 235
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: percent reduction of absolute cylinder
timeFrame: up to 14 months
Secondary outcomes:
measure: Lens rotation or misalignment and patient satisfaction
timeFrame: up to 14 months
Other outcomes:
Locations:
city: Chino Hills
country: United States
facility: Contact Hoya Surgical Optics, Inc. for Trial Locations
state: California
city: Santa Maria
country: United States
facility: Shepard Eye Center
state: California
city: Mt. Dora
country: United States
facility: Mid-Florida Eye Center
state: Florida
city: Bloomfield Hills
country: United States
facility: Grosinger, Spigelman & Grey,
state: Michigan
city: Dansas City
country: United States
facility: Silverstein Eye Conters
state: Missouri
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
Study officials:
affiliation: Hoya Surgical Optics, Inc.
name: Kees den Besten
role: STUDY_DIRECTOR
References: