Cataract SenileLuxSmartNCT04523558
Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs
A study testing Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes in people with Cataract Senile, run by Gemini Eye Clinic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Jun 2020to 8 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
- Being tested
- Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyesDevice
Extended depth of field intraocular lens made form hydrophobic material
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (13)
Manifest refraction (sphere, cylinder, axis)
Standard refraction technique
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye
Measured: 6 months
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes
Measured: 6 months
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye
Measured: 6 months
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes
Measured: 6 months
Monocular Defocus Curve
Standard defocus curve with -5.0 to +1.5 D range lenses
Measured: 6 months
Monocular Contrast Sensitivity under photopic and mesopic conditions
Measurement of contrast sensitivity at 2.5 m
Measured: 6 months
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)
Measured: 6 months
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".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start25 Jun 2020
- Primary completion1 Apr 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemini Eye Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Pavel Stodulka, Gemini Eye Clinic
- Investigators
- Pavel Stodulka, Principal investigator, Gemini Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523558
- Sponsor's protocol ID
- LuxSmart_2020
- Acronym
- LuxSmart
- Status last verified
- Apr 2023
- First submitted
- 19 Aug 2020
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04523558
- Acronym / sponsor ID
- LuxSmart / LuxSmart_2020
- Conditions
- Cataract Senile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gemini Eye ClinicIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral implantation of LuxSmart hydrophobic IOL | Experimental | Device: Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyesCataract 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyesExtended depth of field intraocular lens made form hydrophobic material | Device | Bilateral implantation of LuxSmart hydrophobic IOL |
Primary outcome
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
13 secondary outcomes
Manifest refraction (sphere, cylinder, axis)
Time frame: 6 months
Monocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 6 months
Binocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 6 months
Monocular Corrected Distance Visual Acuity (CDVA)
Time frame: 6 months
Binocular Corrected Distance Visual Acuity (CDVA)
Time frame: 6 months
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 6 months
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 6 months
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 6 months
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 6 months
Monocular Defocus Curve
Time frame: 6 months
Monocular Contrast Sensitivity under photopic and mesopic conditions
Time frame: 6 months
Change in the 9-item Catquest short-form questionnaire (Catquest-9SF) score
Time frame: 6 months
Overall Spectacle independence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Stodulka principal investigator
Gemini Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes in people with Cataract Senile, run by Gemini Eye Clinic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected Distance Visual Acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.