- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504343
Assessing The Visual Performance Of Hanita Lenses "Intensity SL" Intraocular Lens
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Chennai, India
- Agrawal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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)
- 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
Exclusion Criteria:
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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single Arm
This study is a prospective, single arm single center, open label study.
|
Cataract surgery and intraocular lens implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binocular Visual Acuity
Time Frame: 3 months
|
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. |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defocus Curve
Time Frame: 3 months
|
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. |
3 months
|
Contrast Sensitivity
Time Frame: 3 months
|
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. |
3 months
|
Patients Satisfaction
Time Frame: 3 months
|
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 |
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity after IOL implantation
Time Frame: 3 months
|
Occurrence of adverse events associated with treating patients diagnosed with binocular cataract with Intensity SL IOL implantation.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dr. Suvodip Shaw, Dr. Agarwal's Eye Hospital Limited
- Principal Investigator: Dr Ashvin Agarwal, Dr. Agarwal's Eye Hospital Limited
- Study Chair: Priyanka S., Dr. Agarwal's Eye Hospital Limited
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HTF-PM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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