Clinical trial NCT01191229: Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)
Official title: Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens AO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: To Collect Information About Visual Outcomes and Participant Satisfaction
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.


Eligibility criteria: Inclusion Criteria:

* Key Inclusion Criteria for Part 1:

  * 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 (BCDVA) worse than 20/40 Snellen
  * Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
  * Preoperative corneal astigmatism of 1.5 D or less
  * Clear intraocular media other than cataract
  * Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Inclusion Criteria for Part 2

* At least 18 years of age
* Underwent bilateral implantation with Crystalens AO at least 6 months previously
* Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
* Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
* Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
* Preoperative corneal astigmatism of 1.5 D or less
* Clear intraocular media other than cataract
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Key Exclusion Criteria for Part 1:

  * 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
  * Patients with forme fruste keratoconus or keratoconus
  * 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 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

Exclusion Criteria for Part 2

* 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
* Patients with forme fruste keratoconus or keratoconus
* 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)
* Requiring an intraocular lens \<15.0 or \>26.0 diopters Exclusion Criteria for Part 2
* 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
* Patients with forme fruste keratoconus or keratoconus
* 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)
* Requiring an intraocular lens \<15.0 or \>26.0 diopters

Primary outcomes:
measure: Incision size
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Villa
country: United States
facility: JacksonEye
state: Illinois
Study officials:
References: