Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
Primary Purpose
Inclusion Criteria
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Scharioth" macula lens A45sml/A45smy
Sponsored by
About this trial
This is an interventional other trial for Inclusion Criteria
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Add on lens
Arm Description
Outcomes
Primary Outcome Measures
near visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT03061682
First Posted
December 1, 2016
Last Updated
February 19, 2017
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03061682
Brief Title
Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
Official Title
Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inclusion Criteria
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Add on lens
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
"Scharioth" macula lens A45sml/A45smy
Intervention Description
Implantation of an add on intraocular lens to low vision patients
Primary Outcome Measure Information:
Title
near visual acuity
Time Frame
last study visit - 6 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
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