AphakiaNCT05290870
Registry Study on Intraocular Lenses Manufactured by Teleon Surgical B.V.
An observational study of Aphakia and Cataract, run by Teleon Surgical B.V. at 1 site in Netherlands.
Trial summary
This is a retrospective, observational (Registry) study aiming to collect safety and performance data on the use of intraocular lenses (IOLs) manufactured by Teleon Surgical B.V. according to routine practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphakia, Cataract, Clear Lens Exchange
- What is being tested?
- Posterior-chamber intraocular lens
- Type of treatment
- Medical device
- How many people
- 2,183 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2022to 30 Apr 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who have undergone uni- or bilateral extraction of the crystalline lens by means of phacoemulsification or femtosecond laser-assisted cataract surgery with implantation of the subject IOL.
Who may be able to join
- Patients older than 18 years
- Diagnosis of cataract in at least one eye or seeking clear/refractive lens exchange
- Provide consent to retrospective data collection
Who cannot join
- Patients younger than 18 years
- Patients with congenital primary aphakia or secondary aphakia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry Study on Hydrophilic (HydroSmart) and Hydrophobic (ACUNEX) Intraocular Lenses Manufactured by Teleon Surgical B.V.
This is a retrospective, observational (Registry) study aiming to collect safety and performance data on the use of intraocular lenses (IOLs) manufactured by Teleon Surgical B.V. according to routine practice.
- Conditions
- Aphakia, Cataract, Clear Lens Exchange, Refractive Lens Exchange
- Being tested
- Posterior-chamber intraocular lens
- Keywords
- Pseudoaphakia
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior-chamber intraocular lensDevice
Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens
| Study group | Role | What they receive |
|---|---|---|
| Subjects implanted with hydrophilic acrylic IOLs | Subjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS) Receives: Device: Posterior-chamber intraocular lens | |
| Subjects implanted with hydrophobic acrylic IOLs | Subjects were implanted with an ACUNEX IOL Receives: Device: Posterior-chamber intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (uncorrected and/or corrected)
Monocular visual acuity measured under photopic conditions from preoperative to Month 24 using standard methods (e.g. Snellen Chart 6/6-metre, 1.0 decimal or 0.0 logMAR) at standard distances (4 m for far, 65-80 cm for intermediate and 35-40 cm for near distance), depending on IOL optical design, as follows:
For monofocal IOLs:
- Uncorrected and corrected distance visual acuity
For monofocal toric IOLs:
- Uncorrected and corrected distance visual acuity
- Residual astigmatism
- IOL rotation
For multifocal IOLs:
- Uncorrected and corrected distance visual acuity
- Uncorrected and corrected near visual acuity
- Uncorrected and corrected intermediate visual acuity, if available
For multifocal toric IOLs:
- Uncorrected and corrected distance visual acuity
- Uncorrected and corrected near visual acuity
- Uncorrected and corrected intermediate visual acuity, if available
- Residual astigmatism
- IOL rotation
Measured: Preoperatively to Month 24
Secondary outcomes (2)
Adverse events and adverse device effects
Measured: Usual follow-up: 24 Months
Patient and user satisfaction
Satisfaction of the patient with the outcomes of the procedure/medical device Satisfaction of the user with handling of the medical device and patients outcomes
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Feb 2022
- Primary completion29 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teleon Surgical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MaganaMed GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290870
- Sponsor's protocol ID
- PMCF-01-ACX-HS-2022
- Status last verified
- Jul 2024
- First submitted
- 11 Mar 2022
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study on Hydrophilic (HydroSmart) and Hydrophobic (ACUNEX) Intraocular Lenses Manufactured by Teleon Surgical B.V.
- ClinicalTrials.gov ID
- NCT05290870
- Acronym / sponsor ID
- PMCF-01-ACX-HS-2022
- Conditions
- Aphakia, Cataract, Clear Lens Exchange, Refractive Lens Exchange
- Keywords
- Pseudoaphakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,183 participants (actual)
- Lead sponsor
- Teleon Surgical B.V.Industry (pharma, biotech, devices)
- Collaborators
- MaganaMed GmbH
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 Mar 2022 (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 is a retrospective, observational (Registry) study aiming to collect safety and performance data on the use of intraocular lenses (IOLs) manufactured by Teleon Surgical B.V. according to routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects implanted with hydrophilic acrylic IOLs | – | Device: Posterior-chamber intraocular lensSubjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS) |
| Subjects implanted with hydrophobic acrylic IOLs | – | Device: Posterior-chamber intraocular lensSubjects were implanted with an ACUNEX IOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone uni- or bilateral extraction of the crystalline lens by means of phacoemulsification or femtosecond laser-assisted cataract surgery with implantation of the subject IOL.
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Diagnosis of cataract in at least one eye or seeking clear/refractive lens exchange
- Provide consent to retrospective data collection
Key exclusion criteria (2 listed)
- Patients younger than 18 years
- Patients with congenital primary aphakia or secondary aphakia
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 |
|---|---|---|
| Posterior-chamber intraocular lensImplantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens | Device | Subjects implanted with hydrophilic acrylic IOLs, Subjects implanted with hydrophobic acrylic IOLs |
Primary outcome
Visual acuity (uncorrected and/or corrected)
Time frame: Preoperatively to Month 24
Monocular visual acuity measured under photopic conditions from preoperative to Month 24 using standard methods (e.g. Snellen Chart 6/6-metre, 1.0 decimal or 0.0 logMAR) at standard distances (4 m for far, 65-80 cm for intermediate and 35-40 cm for near distance), depending on IOL optical design, as follows: For monofocal IOLs: • Uncorrected and corrected distance visual acuity For monofocal toric IOLs: * Uncorrected and corrected distance visual acuity * Residual astigmatism * IOL rotation For multifocal IOLs: * Uncorrected and corrected distance visual acuity * Uncorrected and corrected near visual acuity * Uncorrected and corrected intermediate visual acuity, if available For multifocal toric IOLs: * Uncorrected and corrected distance visual acuity * Uncorrected and corrected near visual acuity * Uncorrected and corrected intermediate visual acuity, if available * Residual astigmatism * IOL rotation
2 secondary outcomes
Adverse events and adverse device effects
Time frame: Usual follow-up: 24 Months
Patient and user satisfaction
Time frame: Month 1
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 3 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphakia and Cataract, run by Teleon Surgical B.V. at 1 site in Netherlands.
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 3 inclusion and 2 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 3 Jul 2024. 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 Netherlands. 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?
Visual acuity (uncorrected and/or corrected) (time frame: Preoperatively to Month 24). 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 3 Jul 2024.