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CompletedNCT04523558LuxSmartUpdated Apr 19, 2023

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

An interventional study of Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes in Cataract Senile, sponsored by Gemini Eye Clinic. Completed at 1 site in Czechia. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by Gemini Eye Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract Senile

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03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 33 is below the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Gemini Eye Clinic is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations.

Exclusion criteria

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;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    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

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

Interventions

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

    Extended depth of field intraocular lens made form hydrophobic material

06

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. Manifest refraction (sphere, cylinder, axis)

    Standard refraction technique

    Time frame: 6 months

  2. Monocular Uncorrected Distance Visual Acuity (UDVA)

    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

    Time frame: 6 months

  3. Binocular Uncorrected Distance Visual Acuity (UDVA)

    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

    Time frame: 6 months

  4. Monocular Corrected Distance Visual Acuity (CDVA)

    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

    Time frame: 6 months

  5. Binocular Corrected Distance Visual Acuity (CDVA)

    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

    Time frame: 6 months

  6. Monocular Uncorrected Intermediate Visual Acuity (UIVA)

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

    Time frame: 6 months

  7. Binocular Uncorrected Intermediate Visual Acuity (UIVA)

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

    Time frame: 6 months

  8. Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)

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

    Time frame: 6 months

  9. Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)

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

    Time frame: 6 months

  10. Monocular Defocus Curve

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

    Time frame: 6 months

  11. Monocular Contrast Sensitivity under photopic and mesopic conditions

    Measurement of contrast sensitivity at 2.5 m

    Time frame: 6 months

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

    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)

    Time frame: 6 months

  13. Overall Spectacle independence

    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".

    Time frame: 6 months

07

Study locations

1 site
  • Gemini Eye Clinic
    Zlín, 760 01, Czechia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2020 to primary completion in Apr 2021, 9 months.

Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's 9 months is below that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2020
First posted
Aug 21, 2020
StartActual
Jun 25, 2020
Primary completionActual
Apr 1, 2021
CompletionActual
Apr 8, 2021
Last update
Apr 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04523558
Lead sponsor
Gemini Eye Clinic
Responsible party
Dr. Pavel Stodulka (Chief Eye Surgeon, Gemini Eye Clinic) — Principal investigator
First posted
Aug 21, 2020
Start date
Jun 25, 2020
Primary completion
Apr 1, 2021
Completion
Apr 8, 2021
Last update
Apr 19, 2023

Study contacts

Pavel Stodulka
principal investigator · Gemini Eye Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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