Intraocular LensCLAINTNCT05697978
Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens
A study testing Monofocal intraocular lens Clareon (Alcon LLC) in people with Intraocular Lens, run by Faculty Hospital Kralovske Vinohrady at 3 sites in Czechia.
Trial summary
To get the visual outcomes for distance and intermediate and binocular defocus curve in patients with implanted monofocal intraocular lens Clareon (IOL; model SY60CL; Alcon Vision LLC) at 3 months after the surgery. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Lens
- What is being tested?
- Monofocal intraocular lens Clareon (Alcon LLC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 Oct 2022to 1 Aug 2023
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presence of cataract in both eyes
- no other ocular pathology affecting visual acuity
- bilateral phacoemulsification cataract surgery was arranged for both eyes
- corneal astigmatism up to 0,5 cylinder (measured by IOL Master biometry)
- dioptric power of both selective lens within 1,5 D range in one patient
- selecting IOL power between 15 D and 28 D power range
Who cannot join
- complicated cataract
- corneal opacities or irregularities
- amblyopia
- anisometropia
- coexisting ocular pathologies
- glaucoma
- history of ocular surgery
- refusal or unable to maintain follow-up
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites, 3 recruiting
- Recruiting
Somich Eye Clinic
Karlovy Vary, 36001
Pavel Studeny, MD, 775555342, StudenyPavel@seznam.cz
- Recruiting
Eye Center Prague
Prague, Czech Republic, 11000
Andrea Janekova, MD, +420775727002, janekovaandrea@gmail.com
- Recruiting
Faculty hospital Kralovske Vinohrady
Prague, Czech Republic, 11000
Andrea Janekova, MD, +420775727002, janekovaandrea@gmail.com
About this study
To get the visual outcomes for distance and intermediate and binocular defocus curve in patients with implanted monofocal intraocular lens Clareon (IOL; model SY60CL; Alcon Vision LLC) at 3 months after the surgery.
Read the detailed description
The goal of refractive cataract surgery is to remove the opacity, or cataract and to produce the desired refractive outcome. In most cases, the desired outcome is an emmetropic eye, or an eye that sees 20/20 Snellen for distance vision post-surgery with the implant of a monofocal IOL. This, however, does not offer much in the way of intermediate and near vision. The increased desire for simultaneous distance, intermediate and near vision has increased the popularity of multifocal IOLs (MIOLs). However MIOLs provide visual acuity for all distances, they has occurence of optical phenomena such as glare and halo and lower contrast sensitivity. Extended depth of focus (EDOF) lens should provide distance vision as good as monofocal lens and intermediate vision better than monofocal but without or with less appearance of optical phenomenon or decreased contrast sensitivity.
This study is prospective, multi-center, conducted from 10/2022 to 08/2023 in the Ophthalmology department of Faculty Hospital Kralovske Vinohrady in Prague, in Eye Center Prague and Eye Clinic SOMICH (Karlovy Vary). The research protocol was explained to all participants and informed consent was signed before enrolling patient to the study. The study was approved by the Ethics Committee of Faculty Hospital Kralovske Vinohrady and will enrolled up to 100 patients with presence of cataract in both eyes.
Bilateral clear corneal phacoemulsification and IOL implantation is performed by two experienced surgeon using the same technique in both eyes. The surgical process involved topical anesthesia, superior 3-step clear corneal incision (2,2mm), 5,0mm curvilinear capsulorhexis, phacoemulsification, bilateral irrigation- aspiration and implantation of monofocal aspheric intraocular lens (Clareon Alcon vision LLC).
Patients are scheduled for visit at 3 months after the surgery.
- Conditions
- Intraocular Lens
- Being tested
- Monofocal intraocular lens Clareon (Alcon LLC)
- Keywords
- intraocular lens, monofocal lens, intermediate visual acuity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofocal intraocular lens Clareon (Alcon LLC)Device
monofocal aspheric lens implanted in eyes of patient during routine cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Monofocal lens | Other | Eyes of patients with implanted monofocal aspheric lens Clareon (Alcon LLC) Receives: Device: Monofocal intraocular lens Clareon (Alcon LLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular corrected Distance Visual Acuity (CDVA)
Monocular corrected distance visual acuity (CDVA) is measured at 4 m using an ETDRS (Early Treatment Diabetic Retinopathy Study) illumination cabinet (Precision Vision) under photopic conditions.
Measured: 3 months
Binocular corrected Distance Visual Acuity (CDVA)
Binocular corrected distance visual acuity (CDVA) is measured at 4 m using an ETDRS (Early Treatment Diabetic Retinopathy Study) illumination cabinet (Precision Vision) under photopic conditions.
Measured: 3 months
Monocular uncorrected intermediate visual acuity (UIVA)
Monocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Measured: 3 months
Binocular uncorrected intermediate visual acuity (UIVA)
Binocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Measured: 3 months
Monocular distance corrected intermediate visual acuity (DCIVA)
Monocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Measured: 3 months
Binocular distance corrected intermediate visual acuity (DCIVA)
Binocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Measured: 3 months
Secondary outcomes (1)
Binocular defocus curve
A defocus curve that measures visual acuity should be obtained by using the best corrected distance refraction and then defocusing the image in 0.5 increments from +1.5 to -3.0 diopter with spherical plus and spherical minus trial lenses (i.e.,+1.5 D, +1.0 D, +0.5 D, 0.00 D, -0.5 D, -1.00 D, . . . ,-2.50 D) with visual acuity recorded at each change in correction.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Oct 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraocular LensStudies 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
- Model description
- each patient in group received monofocal intraocular lens in both eyes
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Collaborators
- Očni centrum Praha a.s., Somich, s.r.o.
- Responsible party
- Principal investigator, Andrea Janekova, Faculty Hospital Kralovske Vinohrady
- Investigators
- Andrea Janekova, MD, Principal investigator, Eye Center Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697978
- Sponsor's protocol ID
- CZ-001
- Acronym
- CLAINT
- Status last verified
- Feb 2023
- First submitted
- 15 Jan 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lehmann R, Maxwell A, Lubeck DM, Fong R, Walters TR, Fakadej A. Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol. 2021 Apr 20;15:1647-1657. doi: 10.2147/OPTH.S295008. eCollection 2021.
PubMed 33907378Werner L, Thatthamla I, Ong M, Schatz H, Garcia-Gonzalez M, Gros-Otero J, Canones-Zafra R, Teus MA. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019 Oct;45(10):1490-1497. doi: 10.1016/j.jcrs.2019.05.017. Epub 2019 Aug 6.
PubMed 31399323Bala C, Poyales F, Guarro M, Mesa RR, Mearza A, Varma DK, Jasti S, Lemp-Hull J. Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL. J Cataract Refract Surg. 2022 Feb 1;48(2):136-143. doi: 10.1097/j.jcrs.0000000000000712.
PubMed 34288635
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens
- ClinicalTrials.gov ID
- NCT05697978
- Acronym / sponsor ID
- CLAINT / CZ-001
- Conditions
- Intraocular Lens
- Keywords
- intraocular lens, monofocal lens, intermediate visual acuity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Collaborators
- Očni centrum Praha a.s., Somich, s.r.o.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 26 Jan 2023 (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.
To get the visual outcomes for distance and intermediate and binocular defocus curve in patients with implanted monofocal intraocular lens Clareon (IOL; model SY60CL; Alcon Vision LLC) at 3 months after the surgery.
Detailed description
The goal of refractive cataract surgery is to remove the opacity, or cataract and to produce the desired refractive outcome. In most cases, the desired outcome is an emmetropic eye, or an eye that sees 20/20 Snellen for distance vision post-surgery with the implant of a monofocal IOL. This, however, does not offer much in the way of intermediate and near vision. The increased desire for simultaneous distance, intermediate and near vision has increased the popularity of multifocal IOLs (MIOLs). However MIOLs provide visual acuity for all distances, they has occurence of optical phenomena such as glare and halo and lower contrast sensitivity. Extended depth of focus (EDOF) lens should provide distance vision as good as monofocal lens and intermediate vision better than monofocal but without or with less appearance of optical phenomenon or decreased contrast sensitivity.
This study is prospective, multi-center, conducted from 10/2022 to 08/2023 in the Ophthalmology department of Faculty Hospital Kralovske Vinohrady in Prague, in Eye Center Prague and Eye Clinic SOMICH (Karlovy Vary). The research protocol was explained to all participants and informed consent was signed before enrolling patient to the study. The study was approved by the Ethics Committee of Faculty Hospital Kralovske Vinohrady and will enrolled up to 100 patients with presence of cataract in both eyes.
Bilateral clear corneal phacoemulsification and IOL implantation is performed by two experienced surgeon using the same technique in both eyes. The surgical process involved topical anesthesia, superior 3-step clear corneal incision (2,2mm), 5,0mm curvilinear capsulorhexis, phacoemulsification, bilateral irrigation- aspiration and implantation of monofocal aspheric intraocular lens (Clareon Alcon vision LLC).
Patients are scheduled for visit at 3 months after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- each patient in group received monofocal intraocular lens in both eyes
| Arm | Type | Receives |
|---|---|---|
| Monofocal lens | Other | Device: Monofocal intraocular lens Clareon (Alcon LLC)Eyes of patients with implanted monofocal aspheric lens Clareon (Alcon LLC) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- presence of cataract in both eyes
- no other ocular pathology affecting visual acuity
- bilateral phacoemulsification cataract surgery was arranged for both eyes
- corneal astigmatism up to 0,5 cylinder (measured by IOL Master biometry)
- dioptric power of both selective lens within 1,5 D range in one patient
Key exclusion criteria (8 listed)
- complicated cataract
- corneal opacities or irregularities
- amblyopia
- anisometropia
- coexisting ocular pathologies
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 |
|---|---|---|
| Monofocal intraocular lens Clareon (Alcon LLC)monofocal aspheric lens implanted in eyes of patient during routine cataract surgery | Device | Monofocal lens |
Primary outcome
Monocular corrected Distance Visual Acuity (CDVA)
Time frame: 3 months
Monocular corrected distance visual acuity (CDVA) is measured at 4 m using an ETDRS (Early Treatment Diabetic Retinopathy Study) illumination cabinet (Precision Vision) under photopic conditions.
Binocular corrected Distance Visual Acuity (CDVA)
Time frame: 3 months
Binocular corrected distance visual acuity (CDVA) is measured at 4 m using an ETDRS (Early Treatment Diabetic Retinopathy Study) illumination cabinet (Precision Vision) under photopic conditions.
Monocular uncorrected intermediate visual acuity (UIVA)
Time frame: 3 months
Monocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Binocular uncorrected intermediate visual acuity (UIVA)
Time frame: 3 months
Binocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Monocular distance corrected intermediate visual acuity (DCIVA)
Time frame: 3 months
Monocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Binocular distance corrected intermediate visual acuity (DCIVA)
Time frame: 3 months
Binocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
1 secondary outcome
Binocular defocus curve
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Results publication: PubMed 33907378Lehmann R, Maxwell A, Lubeck DM, Fong R, Walters TR, Fakadej A. Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol. 2021 Apr 20;15:1647-1657. doi: 10.2147/OPTH.S295008. eCollection 2021.
- Results publication: PubMed 31399323Werner L, Thatthamla I, Ong M, Schatz H, Garcia-Gonzalez M, Gros-Otero J, Canones-Zafra R, Teus MA. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019 Oct;45(10):1490-1497. doi: 10.1016/j.jcrs.2019.05.017. Epub 2019 Aug 6.
- Results publication: PubMed 34288635Bala C, Poyales F, Guarro M, Mesa RR, Mearza A, Varma DK, Jasti S, Lemp-Hull J. Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL. J Cataract Refract Surg. 2022 Feb 1;48(2):136-143. doi: 10.1097/j.jcrs.0000000000000712.
- 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.
Andrea Janekova, MD principal investigator
Eye Center Prague
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monofocal intraocular lens Clareon (Alcon LLC) in people with Intraocular Lens, run by Faculty Hospital Kralovske Vinohrady at 3 sites 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Janekova, MD (+420775727002, janekovaandrea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular corrected Distance Visual Acuity (CDVA) (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697978, which also lists 3 linked publications.
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 23 Feb 2023.