Skip to main content
OpenTrials
Completed

NCT Number: NCT04523558

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gemini Eye Clinic

Zlín, 760 01, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Device

Extended depth of field intraocular lens made form hydrophobic material

Primary outcomes

  1. Corrected Distance Visual Acuity

    Time frame: 6 months

    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

Secondary outcomes

  1. Manifest refraction (sphere, cylinder, axis)

    Time frame: 6 months

    Standard refraction technique

  2. Monocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 6 months

    Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance without corrective glasses for each eye separately

  3. Binocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 6 months

    Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance without corrective glasses for both eyes together

  4. Monocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 6 months

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

  5. Binocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 6 months

    Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance with corrective glasses for both eyes together

  6. Monocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 6 months

    Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye

  7. Binocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 6 months

    Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes

  8. Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)

    Time frame: 6 months

    Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye

  9. Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)

    Time frame: 6 months

    Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes

  10. Monocular Defocus Curve

    Time frame: 6 months

    Standard defocus curve with -5.0 to +1.5 D range lenses

  11. Monocular Contrast Sensitivity under photopic and mesopic conditions

    Time frame: 6 months

    Measurement of contrast sensitivity at 2.5 m

  12. Change in the 9-item Catquest short-form questionnaire (Catquest-9SF) score

    Time frame: 6 months

    To assess if difficulties in daily life occur due to impaired sight. This questionnaire is 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery. There are five text response options for the answers scaled from "Yes, very great difficulties" to "No, no difficulties" including answer "Cannot decide". Outcome is a sum score (min: 9, max: 36, lower scores mean a better result)

  13. Overall Spectacle independence

    Time frame: 6 months

    Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ - "a little of the time" or "none of the time".

Sponsors and collaborators

Lead sponsor

Gemini Eye Clinic

Industry

Registry information

Official study title

Evaluation of the Extended Depth of Focus After Bilateral Implantation of a Hydrophobic IOL With a New Optic Concept Based on a Combination of High Order Aberrations

Acronym: LuxSmart

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.