Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs

NCT ID: NCT04523558

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2021-04-08

Brief Summary

This will be a prospective observational, ethics committee approved study where patients undergoing routine cataract surgery will have bilateral implantation of the intraocular lens (LuxSmart, Bausch & Lomb). The device under investigation is CE-mark approved and commercially available. The device under investigation and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.

Investigator is accredited and experienced cataract surgeon and researchers who have been involved in similar studies in the past.

The device under investigation LuxSmart (Bausch & Lomb) is a hydrophobic, acrylic copolymer containing UV absorber intraocular lens (IOL). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 30 patients will be recruited for this first clinical experience and receive bilateral implantation of the LuxSmart. The maximum time between 1st and 2nd eye implantation is 30 days, some patients may receive bilateral implantation on the same day. However there will be a minimum of 1 week between the implantations in the first 10 patients.

Conditions

Cataract Senile

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bilateral implantation of LuxSmart hydrophobic IOL

Cataract surgery will be carried out using standard phacoemulsification technique with a 2.2 mm incision. Investigators will target a 5.5 mm diameter capsulorhexis to allow the optic to be fully overlapped by the anterior capsular rim.

The intended target of the post-operative refraction will be emmetropia. The patient will be implanted with LuxSmart hydrophobic IOLs in both eyes and followed up for 6 months

Group Type: EXPERIMENTAL

Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes

Intervention Type: DEVICE

Extended depth of field intraocular lens made form hydrophobic material

Interventions

Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes

Extended depth of field intraocular lens made form hydrophobic material

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Cataractous eyes with no comorbidity;
• Calculated IOL power is within the range of the study IOLs;
• Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
• Regular corneal astigmatism ≤1.5D (measured by an automatic keratometry) in one or both eyes;
• Clear intraocular media other than cataract;
• Dilated pupil size large enough to visualize IOL axis markings postoperatively
• Availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits.
• Subjects able to read, understand and provide written Informed Consent Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations.

Exclusion Criteria

• Age of patient <50 years;
• Regular corneal astigmatism >1.5D (measured by an automatic keratometry) in both eyes;
• Irregular astigmatism;
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
• Subjects with AMD suspicious eyes as determined by OCT examination;
• Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
• Previous intraocular or corneal surgery;
• Traumatic cataract;
• History or presence of macular edema;
• Instability of keratometry or biometry measurements;
• Advanced or decompensated glaucoma;
• Significant dry eye;

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gemini Eye Clinic

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Pavel Stodulka

Chief Eye Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pavel Stodulka

Role: PRINCIPAL_INVESTIGATOR

Gemini Eye Clinic

Locations

Gemini Eye Clinic

Zlín, , Czechia

Countries

Czechia

Other Identifiers

LuxSmart_2020

Identifier Type: -

Identifier Source: org_study_id