Clinical trial NCT01061918: Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses
Official title: Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs 6 months post cataract surgery.
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18 or greater
* Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
* Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
* Preoperative best-corrected distance visual acuity (BSDVA) worse than 20/40 Snellen. If there is a glare component, glare testing which reduces the visual acuity to less than 20/40
* Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
* Preoperative corneal astigmatism of 1.0 D or less
* Clear intraocular media other than cataract
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Use of systemic or ocular medications that may affect vision
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
* Subjects with diabetes mellitus
* Uncontrolled systemic or ocular disease
* History of ocular trauma or prior ocular surgery
* Amblyopia or strabismus
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
* Subjects who may be expected to require retinal laser treatment or other surgical intervention
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
* Contact lens usage within 6 months for polymethyl methacrylate (PMMA) contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
* Requiring an intraocular lens \<15.0 or \>26.0 diopters

Primary outcomes:
measure: Refraction
timeFrame: 1 year
measure: Distance Visual Acuities
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: William Trattler
state: Florida
city: Sarasota
country: United States
facility: William Lahners
state: Florida
Study officials:
References: