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Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism

C

Calhoun Vision

Status

Completed

Conditions

Cataract

Treatments

Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
Device: Monofocal control IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01496066
CSP-002-03

Details and patient eligibility

About

The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.

Enrollment

600 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted
  • Pre-operative regular corneal astigmatism of >= 0.75 diopters and <= 2.0 diopters
  • Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare
  • Projected best spectacle corrected visual acuity of 20/20 or better
  • Clear intraocular media other than cataract
  • Potentially good vision in fellow eye
  • Fully dilated pupil of >= 7.0 mm

Exclusion criteria

  • Zonular laxity or dehiscence
  • Pseudoexfoliation
  • Age related macular degeneration
  • Retinal degenerative disorder
  • Diabetes with any evidence of retinopathy
  • Glaucomatous optic neuropathy, uveitis, significant anterior segment pathology, keratoconus
  • Corneal dystrophy, previous corneal or intraocular surgery
  • Complications during cataract surgery
  • Serious co-morbid conditions
  • Systemic medications that my increase UV sensitivity
  • Irregular astigmatism

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

600 participants in 2 patient groups

LAL
Experimental group
Description:
LAL implanted
Treatment:
Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
Monofocal control
Active Comparator group
Description:
Monofocal control IOL implanted
Treatment:
Device: Monofocal control IOL

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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