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

NCT01496066 | Completed Results

• 1 other identifier: CSP-002-03
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• Percent Reduction in Manifest Cylinder

  Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.

  6 months

• Percent Absolute Reduction in MRSE

  Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.

  6 months

• Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop

  Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.

  6 months

Secondary Outcomes (5)

• Uncorrected Visual Acuity 20/20 or Better

  6 months

• Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)

  6 months

• Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)

  6 months

• Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively

  6 months

• Mean BSCVA

  6 months

Study Arms (2)

LAL

EXPERIMENTAL

LAL implanted

Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)

Monofocal control

ACTIVE COMPARATOR

Monofocal control IOL implanted

Device: Monofocal control IOL

Interventions

LAL (Light Adjustable Lens) and Light Deliver Device (LDD) DEVICE

LAL implanted and adjusted with LDD

LAL

Monofocal control IOL DEVICE

Commercially available monofocal intraocular lens (IOL)

Monofocal control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Calhoun Vision, Inc.: lead

Study Sites (17)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Newsom Eye

Sebring, Florida, 33870, United States

Location

Arbor Centers for Eye Care

Orland Park, Illinois, 60467, United States

Location

Eye Surgeons of Indiana

Indianapolis, Indiana, 46256, United States

Location

Jones Eye Clinic

Sioux City, Iowa, 51104, United States

Location

Discover Vision & Laser Center

Leawood, Kansas, 66211, United States

Location

Minnesota Eye Consultants, PA

Bloomington, Minnesota, 55431, United States

Location

Ophthalmology Consultants, Ltd.

St Louis, Missouri, 63131, United States

Location

EyeSight Ophthalmic Services, PA

Somersworth, New Hampshire, 03878, United States

Location

Carolina Vision Center

Fayetteville, North Carolina, 28304, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57105, United States

Location

Eye Consultants of Texas

Grapevine, Texas, 76051, United States

Location

Focal Point Vision

San Antonio, Texas, 78229, United States

Location

Hoopes Vision

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Maureen O'Connell Vice President, Regulator and Clinical Affairs
• Organization: RxSight, Inc.

moconnell@rxsight.com

978-207-12415

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 3 medical device study

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 21, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 29, 2018
• Results First Posted: March 5, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)