Inclusion CriteriaNCT03061682
Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
A study testing "Scharioth" macula lens A45sml/A45smy in people with Inclusion Criteria, run by Rabin Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Inclusion Criteria
- What is being tested?
- "Scharioth" macula lens A45sml/A45smy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2017to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pseudophakic patients with non-active AMD that complain on near distance reading with a distance visual acuity better than 6/60.
Who cannot join
- 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.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Inclusion Criteria
- Being tested
- "Scharioth" macula lens A45sml/A45smy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Scharioth" macula lens A45sml/A45smyDevice
Implantation of an add on intraocular lens to low vision patients
| Study group | Role | What they receive |
|---|---|---|
| Add on lens | Experimental | Not described Receives: Device: "Scharioth" macula lens A45sml/A45smy |
What is being measured
The primary outcome is the main question the study is designed to answer.
near visual acuity
Measured: last study visit - 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inclusion CriteriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rita ehrlich, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061682
- Sponsor's protocol ID
- 0408-15RMC
- Status last verified
- Feb 2017
- First submitted
- 1 Dec 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
- ClinicalTrials.gov ID
- NCT03061682
- Acronym / sponsor ID
- 0408-15RMC
- Conditions
- Inclusion Criteria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Add on lens | Experimental | Device: "Scharioth" macula lens A45sml/A45smy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pseudophakic patients with non-active AMD that complain on near distance reading with a distance visual acuity better than 6/60.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Scharioth" macula lens A45sml/A45smyImplantation of an add on intraocular lens to low vision patients | Device | Add on lens |
Primary outcome
near visual acuity
Time frame: last study visit - 6 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing "Scharioth" macula lens A45sml/A45smy in people with Inclusion Criteria, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
near visual acuity (time frame: last study visit - 6 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.