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CataractNCT05504343

Assessing The Visual Performance Of Hanita Lenses "Intensity SL" Intraocular Lens

A study testing "Intensity SL" Intraocular Lens in people with Cataract, run by Hanita Lenses at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Hanita Lenses Intensity SL 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… Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Cataract
What is being tested?
"Intensity SL" Intraocular Lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteIndia
Study dates
27 Dec 2021to 9 Jan 2023
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;
  • Calculated IOL power is within range 15-30 Diopter (approximate range of axial lengths: 21-25.5mm)
  • Normal corneas with corneal astigmatism below following value:
  • 1 D if with-the-rule (steep axis is vertical, between 60-120⁰)
  • 0.4 D if against-the-rule (steep axis is horizontal, 0-30⁰ or 150-180⁰)
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  • 0.7 D if oblique (not one of the cases above)
  • Post-operative best corrected visual acuity expected to be 0.3 logMAR or better.
  • Patient motivated for Intensity SL IOL after screening by surgeon.
  • Fundus visualization is possible.
  • Absence of retinal or optic nerve diseases
  • Signed informed consent

Who cannot join

  • Any of the following condition will render a subject ineligible for inclusion in the analysis:
  • 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
Show all 14Show fewer
  • Significantly dry eye
  • Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the Intensity SL lens.
  • 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.

India1 site

  • Agrawal

    Chennai

Other trials in India

About this study

The Hanita Lenses Intensity SL 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, intermediate and far visual functions, and reduced spectacle dependence.

Read the detailed description

Different multifocal intraocular lens (MIOL) designs have been used for more than 25 years1. Unlike conventional mono focal intraocular lenses (IOLs), which bend light to a single focus point on the retina, MIOLs are designed to help patients to see at varying distances using different points of focus2. MIOLs used in clinical practice were either refractive initially, or later diffractive in their optical design. Refractive MIOLs incorporate a lens optic with different optical powers in different parts of the lens, while diffractive MIOLs use diffractive steps on the lens to distribute light rays into two or more principal foci. Irrespective of the design type, however, all MIOLs involve some form of optical compromise and a process of neuroadaptation for the patient3.

Intensity SL intraocular lenses (IOLs) represent the latest in premium lens technology. Intensity SL lenses provide clear vision at all distances - from near to far - thus offering the best chance of true spectacle independence.

Despite the promising results obtained with the latest generation of MIOLs, many surgeons remain reluctant to implant these lenses. Visual symptoms such as glare and haloes, reduced contrast sensitivity and night vision problems are all known complications of multifocal implants and have served to hamper wider acceptance of these IOLs4.

Hanita Lenses new Intensity SL IOL has been designed to have very high efficiency of light leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. The main purpose of this study is to evaluate visual acuity and contrast sensitivity patients receiving the new Intensity SL IOL.

Conditions
Cataract
Being tested
"Intensity SL" Intraocular Lens
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Intensity SL" Intraocular LensDevice

    Cataract surgery and intraocular lens implantation

Study groups in NCT05504343
Study groupRoleWhat they receive
Single ArmOtherThis study is a prospective, single arm single center, open label study.
Receives: Device: "Intensity SL" Intraocular Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Binocular Visual Acuity

    Binocular visual acuity for far, intermediate and near distance are measured using an ETDRS chart or PV numbers for distance and PV Numbers Near Vision Card (Precision Vision) for near (40cm) and intermediate distances (80cm).

    Visual acuity is measured in photopic conditions.

    Measured: 3 months

Secondary outcomes (3)

  1. Defocus Curve

    Defocus Curve is measured using ETDRS chart or PV numbers. A loss of ≥ 3 lines (≥ 15 letters) on an ETDRS chart is considered moderate visual loss. A loss of ≥ 6 lines (≥ 30 letters) is considered severe.

    Patient's pupil diameter will be evaluated 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: 3 months

  2. Contrast Sensitivity

    Contrast Sensitivity is measured using a sine wave gratings chart (FACT) at mesopic and photopic conditions.

    Luminance for photopic conditions will be 85cd/m² and 5cd/m² for mesopic conditions. 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.

    Measured: 3 months

  3. Patients Satisfaction

    Patient Satisfaction is measured using the modified VF-14 questionnaire for quality of life, in addition to satisfaction questionnaire.

    VF-14 stands for Visual Function questionnaire version 14. Function: High score = better Visual Phenomenon: High score = better Satisfaction: Very happy / Happy / Less Happy / Unhappy

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start27 Dec 2021
  3. Primary completion9 Jan 2023
  4. Study completion9 Jan 2023

Resources

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
Model description
single arm single center, open label study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05504343
Sponsor's protocol ID
HTF-PM
Status last verified
Oct 2023
First submitted
1 Aug 2022
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing "Intensity SL" Intraocular Lens in people with Cataract, run by Hanita Lenses at 1 site in India.

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 12 inclusion and 14 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 3 Oct 2023. 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 India. 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 (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05504343.

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 3 Oct 2023.

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