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

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ClinicalTrials.gov Identifier: NCT03061682
Recruitment Status : Unknown
Verified February 2017 by rita ehrlich, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
rita ehrlich, Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Inclusion Criteria Device: "Scharioth" macula lens A45sml/A45smy Not Applicable

Detailed Description:

Study design Prospective study on implantation of the add on lenses in AMD patients. The study was approved by Rabin medical center IRB.

Patients will be examined for best corrected visual acuity prior to the surgery at 6 meter and for reading at 40 and 15 cm. Improvement of the reading ability at 15 cm compared to 40 cm will predict the potential for vision improvement with the add on lens.

Before the surgery patients will have a full ophthalmological examination. Patients will have axial length and keratometry examination using the biometry. The lens will be implanted in surgery through a 2.2 mm clear cornea and will be injected and positioned in the sulcus.

Patients will be followed up at 1 day, 1 week, 4 weeks, 4 and 6 months following surgery. During follow up patients will undergo full ophthalmic exam and well as visual acuity both for distance and near.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Add on lens Device: "Scharioth" macula lens A45sml/A45smy
Implantation of an add on intraocular lens to low vision patients




Primary Outcome Measures :
  1. near visual acuity [ Time Frame: last study visit - 6 months post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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Responsible Party: rita ehrlich, Principal Investigator, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03061682     History of Changes
Other Study ID Numbers: 0408-15RMC
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Macular Degeneration
Vision, Low
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms