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

NCT05504343 | Completed DMC

• 1 other identifier: HTF-PM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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, intermediate and far visual functions, and reduced spectacle dependence.

Conditions

Cataract

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (3)

• Defocus Curve

  3 months

• Contrast Sensitivity

  3 months

• Patients Satisfaction

  3 months

Other Outcomes (1)

• Toxicity after IOL implantation

  3 months

Study Arms (1)

Single Arm

OTHER

This study is a prospective, single arm single center, open label study.

Device: "Intensity SL" Intraocular Lens

Interventions

"Intensity SL" Intraocular Lens DEVICE

Cataract surgery and intraocular lens implantation

Single Arm

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• D if with-the-rule (steep axis is vertical, between 60-120⁰)
• D if against-the-rule (steep axis is horizontal, 0-30⁰ or 150-180⁰)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (1)

Agrawal

Chennai, India

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Dr. Suvodip Shaw

  Dr. Agarwal's Eye Hospital Limited

  STUDY DIRECTOR

• Dr Ashvin Agarwal

  Dr. Agarwal's Eye Hospital Limited

  PRINCIPAL INVESTIGATOR

• Priyanka S.

  Dr. Agarwal's Eye Hospital Limited

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm single center, open label study

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 17, 2022
• Study Start: December 27, 2021
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Locations

IN (1)