MyopiaNCT01497067
Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
A study testing ACRYSOF CACHET Phakic Lens (L-series) in people with Myopia, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- ACRYSOF CACHET Phakic Lens (L-series)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2011to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously implanted with an ACRYSOF CACHET Phakic Lens (L-Series) from clinical studies C-02-23, C-02-40, C-03-21 and C-05-57 and eligible for continued follow-up (i.e., exited from the previous study).
- Able to understand and sign a statement of informed consent.
- Willing and able to complete the yearly postoperative study visits.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: Long Term Safety Follow-up for Subjects Previously Implanted With the ACRYSOF® CACHET® Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57
The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.
Read the detailed description
Subjects previously enrolled in protocols C-02-23 (NCT00726024), C-02-40 (NCT00727805), C-03-21 (NCT00726297), and C-05-57 (NCT00727688) who received an L-series lens either in the first eye or second eye (including those who were explanted) were enrolled in this open-label, non-randomized, non-controlled, extension study in which they attended postoperative visits for up to 10 years following the date of implantation. Subjects could enroll in the study at any time, thus the Entrance Visit may have coincided with any visit (Year 4 to Year 10).
- Conditions
- Myopia
- Being tested
- ACRYSOF CACHET Phakic Lens (L-series)
- Keywords
- Phakic Lens, Intraocular Lens (IOL)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACRYSOF CACHET Phakic Lens (L-series)Device
Also called AcrySof Angle-Supported Phakic Lens
Intraocular lens for the treatment of moderate to high myopia
| Study group | Role | What they receive |
|---|---|---|
| CACHET | Experimental | ACRYSOF CACHET Phakic Lens (L-series) previously implanted Receives: Device: ACRYSOF CACHET Phakic Lens (L-series) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Endothelial Cell Density (All Eyes)
A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea.
Measured: Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study start21 Nov 2011
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Project Lead, Surgical, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497067
- Sponsor's protocol ID
- C-09-043
- Status last verified
- Jun 2019
- First submitted
- 20 Dec 2011
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Safety Follow-up for Subjects Previously Implanted With the ACRYSOF® CACHET® Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57
- ClinicalTrials.gov ID
- NCT01497067
- Acronym / sponsor ID
- C-09-043
- Conditions
- Myopia
- Keywords
- Phakic Lens, Intraocular Lens (IOL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2011 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Posted 26 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.
Detailed description
Subjects previously enrolled in protocols C-02-23 (NCT00726024), C-02-40 (NCT00727805), C-03-21 (NCT00726297), and C-05-57 (NCT00727688) who received an L-series lens either in the first eye or second eye (including those who were explanted) were enrolled in this open-label, non-randomized, non-controlled, extension study in which they attended postoperative visits for up to 10 years following the date of implantation. Subjects could enroll in the study at any time, thus the Entrance Visit may have coincided with any visit (Year 4 to Year 10).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CACHET | Experimental | Device: ACRYSOF CACHET Phakic Lens (L-series)ACRYSOF CACHET Phakic Lens (L-series) previously implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously implanted with an ACRYSOF CACHET Phakic Lens (L-Series) from clinical studies C-02-23, C-02-40, C-03-21 and C-05-57 and eligible for continued follow-up (i.e., exited from the previous study).
- Able to understand and sign a statement of informed consent.
- Willing and able to complete the yearly postoperative study visits.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ACRYSOF CACHET Phakic Lens (L-series)Also: AcrySof Angle-Supported Phakic LensIntraocular lens for the treatment of moderate to high myopia | Device | CACHET |
Primary outcome
Central Endothelial Cell Density (All Eyes)
Time frame: Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)
A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sr. Project Lead, Surgical study director
Alcon Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACRYSOF CACHET Phakic Lens (L-series) in people with Myopia, run by Alcon Research at 1 site in United States.
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 1 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 2 Jul 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Central Endothelial Cell Density (All Eyes) (time frame: Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)). 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 2 Jul 2019.