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

NCT04523558 | Completed DMC

• 1 other identifier: LuxSmart_2020
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Corrected Distance Visual Acuity

  Measurement of distance visual acuity is measured with 5 letters modified Snellen charts placed at 6 m distance with corrective glasses for each eye separately

  6 months

Secondary Outcomes (13)

• Manifest refraction (sphere, cylinder, axis)

  6 months

• Monocular Uncorrected Distance Visual Acuity (UDVA)

  6 months

• Binocular Uncorrected Distance Visual Acuity (UDVA)

  6 months

• Monocular Corrected Distance Visual Acuity (CDVA)

  6 months

• Binocular Corrected Distance Visual Acuity (CDVA)

  6 months

Study Arms (1)

Bilateral implantation of LuxSmart hydrophobic IOL

EXPERIMENTAL

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

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

Interventions

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

Extended depth of field intraocular lens made form hydrophobic material

Bilateral implantation of LuxSmart hydrophobic IOL

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Gemini Eye Clinic: lead

Study Sites (1)

Gemini Eye Clinic

Zlín, 760 01, Czechia

Location

Study Officials

• Pavel Stodulka

  Gemini Eye Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Eye Surgeon

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: June 25, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 8, 2021
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)