Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision

NCT03061682 | Unknown FDA Device

• 1 other identifier: 0408-15RMC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Age related macular degeneration (AMD) is the leading cause of vision loss in patients older than 55 years old. AMD can present as dry AMD or wet AMD. In most cases AMD affects both eyes although in many cases it's asymmetrical as far as severity. Some patients require low vision aids to continue their daily life tasks. In the past a few attempts were made to use low vision intraocular lenses with corrective glasses without enough success. In addition telescopic and prismatic lenses were also tried. The difficulties with these lenses included low field of vision, unsatisfactory magnification, complicated surgical technique and high complication rates. Recently an add on lens was designed for the sulcus for implantation in pseudophakic AMD patients. The add on lens doubles the magnification of the central image dependent on the reading distance and the anatomy of the eye. The lens is acrylic hydrophobic and designed for implantation in the sulcus either in pseudophakic patients or in addition to an intraocular lens implanted during a routine cataract surgery. The lens is 13 mm wide with 4 symmetric haptics. The lens has 1.5 mm central part of 10 diopters and the rest of the lens has no optical power. Our purpose is to study implantation of the lenses in AMD patients to improve their reading ability and to improve their daily living.

Conditions

Inclusion Criteria

Outcome Measures

Primary Outcomes (1)

• near visual acuity

  last study visit - 6 months post surgery

Study Arms (1)

Add on lens

EXPERIMENTAL

Device: "Scharioth" macula lens A45sml/A45smy

Interventions

"Scharioth" macula lens A45sml/A45smy DEVICE

Implantation of an add on intraocular lens to low vision patients

Add on lens

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pseudophakic patients with non-active AMD that complain on near distance reading with a distance visual acuity better than 6/60.

You may not qualify if:

• Exudative AMD with fluids, advanced glaucoma, advance visual field defects, aphakia, following complicated cataract surgery with PCIOL in the sulcus , phacodonesis, chronic uveitis, rubeosis iridis, central corneal opacity.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 23, 2017

Record last verified: 2017-02