Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

I

Innovative Medical

Status and phase

Completed
Phase 4

Conditions

Aphakia

Treatments

Device: Tecnis MF IOL
Device: Crystalens AO IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01061281
Tecnis MF/Crystalens

Details and patient eligibility

About

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 20/25 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) > 4.0 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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Tecnis MF IOL
Active Comparator group
Treatment:
Device: Tecnis MF IOL
Crystalens AO IOL
Active Comparator group
Treatment:
Device: Crystalens AO IOL

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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