CataractNCT04843748
Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL
A study testing cataract surgery and intraocular lens implantation - both eyes in people with Cataract, run by Hanita Lenses at 1 site in Israel.
Trial summary
Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cataract
- What is being tested?
- cataract surgery and intraocular lens implantation - both eyes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Aug 2018to 6 Jan 2021
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 45 years and under 75 years.
- Patients with bilateral age-related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
- Patients with an axial length of 22-24.5mm.
- Normal corneas with less than 0.75D of regular corneal astigmatism.
- Post-operative best-corrected visual acuity projected to be 0.3 logMAR or lower.
- Patient motivated for trifocal IOL after screening by the surgeon.
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- Fundus visualization is possible.
- Absence of retinal or optic nerve diseases
- Signed informed consent
Who cannot join
- Previous ocular/corneal surgery that may affect refraction accuracy or visual acuity.
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- History or evidence of any ocular disease that may affect visual acuity (i.e. uncontrolled glaucoma, ocular injury, corneal pathologies, retinal pathologies in general and macular pathologies in particular, diabetic retinopathy, uveitis, aniridia or iris atrophy, vitreous pathologies (patients with vitreous separation or floaters can be included).
- Rubella cataract.
- Amblyopia
- Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the trifocal lens.
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- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
- Patients with pupil diameter greater than 4mm in photopic conditions.
- Pregnant, lactating or planning to become pregnant during the course of the trial.
- Allergy or intolerance to required study medications (including antibiotic).
- Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days.
- Traumatic cataract.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study for Assessing the Visual Performance of Hanita Lenses New Trifocal Intraocular Lens
Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.
Read the detailed description
Device: Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL). Indication studied: The Hanita Lenses Trifocal IOL is intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near and intermediate visual functions, and reduced spectacle dependence.
Study description: This study is a prospective, single-arm single-center, open-label study.
- Conditions
- Cataract
- Being tested
- cataract surgery and intraocular lens implantation - both eyes
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgery and intraocular lens implantation - both eyesDevice
cataract surgery and intraocular lens implantation for both eyes
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | single arm open label study Receives: Device: cataract surgery and intraocular lens implantation - both eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation
Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation
Measured: 90-110 days post op
Secondary outcomes (3)
Defocus Curve
Will be obtained using an ETDRS chart or PV numbers. Patient's pupil diameter will be evaluated.
In the statistical stage patients will be categorized according to smaller than 2.5mm, between 2.5 and 4.5mm and above 4.5mm for mesopic and photopic conditions.
The test will be performed using a phoropter to create defocus in 0.5D increments, starting from 1D to -4D relative to emmetropia so that the patient will be corrected for far vision.
Measured: 90-110 days post op
Contrast Sensitivity
Will be evaluated using a sine wave gratings chart (FACT) at mesopic and photopic conditions. Measurements will be performed with optimal refractive correction.
Luminance for photopic conditions will be 85cd/m² and 5cd/m² for mesopic conditions. Small deviations are allowed. The working interval for photopic conditions is 75-95cd/m² and for mesopic conditions is 5-15cd/m².
Luminance for photopic and mesopic conditions will be monitored using Illuminance meter and documented. Results will be expressed as values.
Measured: 90-110 days post op
patient satisfaction
Subjective evaluation will be performed using the modified VF-14 questionnaire for quality of life, in addition to satisfaction questionnaire.
Measured: 90-110 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start18 Aug 2018
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843748
- Sponsor's protocol ID
- HTF-01
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Assessing the Visual Performance of Hanita Lenses New Trifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT04843748
- Acronym / sponsor ID
- HTF-01
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2018 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 14 Apr 2021 (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.
Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.
Detailed description
Device: Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL). Indication studied: The Hanita Lenses Trifocal IOL is intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near and intermediate visual functions, and reduced spectacle dependence.
Study description: This study is a prospective, single-arm single-center, open-label study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: cataract surgery and intraocular lens implantation - both eyessingle arm open label study |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age over 45 years and under 75 years.
- Patients with bilateral age-related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
- Patients with an axial length of 22-24.5mm.
- Normal corneas with less than 0.75D of regular corneal astigmatism.
- Post-operative best-corrected visual acuity projected to be 0.3 logMAR or lower.
Key exclusion criteria (12 listed)
- Previous ocular/corneal surgery that may affect refraction accuracy or visual acuity.
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- History or evidence of any ocular disease that may affect visual acuity (i.e. uncontrolled glaucoma, ocular injury, corneal pathologies, retinal pathologies in general and macular pathologies in particular, diabetic retinopathy, uveitis, aniridia or iris atrophy, vitreous pathologies (patients with vitreous separation or floaters can be included).
- Rubella cataract.
- Amblyopia
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 |
|---|---|---|
| cataract surgery and intraocular lens implantation - both eyescataract surgery and intraocular lens implantation for both eyes | Device | single arm |
Primary outcome
Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation
Time frame: 90-110 days post op
Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation
3 secondary outcomes
Defocus Curve
Time frame: 90-110 days post op
Contrast Sensitivity
Time frame: 90-110 days post op
patient satisfaction
Time frame: 90-110 days post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery and intraocular lens implantation - both eyes in people with Cataract, run by Hanita Lenses at 1 site in Israel.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation (time frame: 90-110 days post op). 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 14 Apr 2021.