CATARACT SURGERYNCT00604305
Comperative Trial Between an Accommodative Iol and Monofocal Iol
A study testing Acrysof and Acuity's AIOL in people with CATARACT SURGERY, run by Shaare Zedek Medical Center.
Trial summary
a comparison of two intraocular lenses in regard of accommodative power. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- CATARACT SURGERY
- What is being tested?
- Acrysof and Acuity's AIOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Dec 2012
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 65
- Required cataract operation in one or both eyes
- BCVA potetial at least 20/30
- Clear intraoccular media
- Willing to participate in study as evidenced by signing a written Informed Consent
Who cannot join
- Prior surgery at the selected eye
- No light perception or poor potential for improvement
- Phacodonesis and damaged zonules
- Pupil size at least 6 mm.
- History of uveitis
- Macular disease decreasing vision below 20/30
- Amblyopia
- Axial length shorter than 21 mm and longer than 25 mm
About this study
Official title: A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof
a comparison of two intraocular lenses in regard of accommodative power.
Read the detailed description
A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.
- Conditions
- CATARACT SURGERY
- Being tested
- Acrysof, Acuity's AIOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrysofDevice
Monofocal IOL
Acuity's AIOLDevice
Accommodating IOL
| Study group | Role | What they receive |
|---|---|---|
| Acrysof | Active comparator | Routine monofocal IOL Receives: Device: Acrysof |
| Acuity's AIOL | Active comparator | Accomodaing IOL Receives: Device: Acuity's AIOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
distance and near visual acuity
Measured: 1 year
Secondary outcomes (1)
centration pco
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Company could not supply the accommodating intraocular lenses for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CATARACT SURGERYStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yaacov Rozenman, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604305
- Sponsor's protocol ID
- 6666476CTIL
- Other IDs
- Rozenman-CWPMS001
- Status last verified
- Jun 2012
- First submitted
- 17 Jan 2008
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof
- ClinicalTrials.gov ID
- NCT00604305
- Acronym / sponsor ID
- 6666476CTIL
- Conditions
- CATARACT SURGERY
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company could not supply the accommodating intraocular lenses for the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 30 Jan 2008 (estimated)
- 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.
a comparison of two intraocular lenses in regard of accommodative power.
Detailed description
A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acrysof | Active comparator | Device: AcrysofRoutine monofocal IOL |
| Acuity's AIOL | Active comparator | Device: Acuity's AIOLAccomodaing IOL |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 30 and 65
- Required cataract operation in one or both eyes
- BCVA potetial at least 20/30
- Clear intraoccular media
- Willing to participate in study as evidenced by signing a written Informed Consent
Key exclusion criteria (8 listed)
- Prior surgery at the selected eye
- No light perception or poor potential for improvement
- Phacodonesis and damaged zonules
- Pupil size at least 6 mm.
- History of uveitis
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 |
|---|---|---|
| AcrysofMonofocal IOL | Device | Acrysof |
| Acuity's AIOLAccommodating IOL | Device | Acuity's AIOL |
Primary outcome
distance and near visual acuity
Time frame: 1 year
1 secondary outcome
centration pco
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acrysof and Acuity's AIOL in people with CATARACT SURGERY, run by Shaare Zedek Medical Center.
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 5 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: withdrawn, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
distance and near visual acuity (time frame: 1 year). 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 12 Jun 2012.