CataractNCT02578524
Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
An observational study of Cataract, run by MDbackline, LLC at 1 site in United States.
Trial summary
This study will examine patient satisfaction and spectacle independence using a survey in patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens at least 2 years prior to administration of the survey. Read more about this study
- Who is it for?
- Ages 1 year to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Survey
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Oct 2015
- 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 1 year to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who underwent cataract surgery with a multifocal or accommodating lens implant at least two years prior to the survey.
Who may be able to join
- Patients with uncomplicated bilateral cataract surgery with either multifocal or accommodating lens implants performed at least 24 months previously
- Patients with or without astigmatic keratotomy or other simultaneous procedures may be included, so long as exclusion criteria are not met.
Who cannot join
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that, in the best judgment of the investigator, could affect their satisfaction with surgery
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
- Patients with ≥ grade 1 posterior capsule opacity at their last visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Eye Associates
Laguna Hills, California, 92653
About this study
This study will examine patient satisfaction and spectacle independence using a survey in patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens at least 2 years prior to administration of the survey.
Read the detailed description
Purpose: To compare patient-reported satisfaction with a multifocal vs an accommodating presbyopia-correcting at least two years following implantation of either type of implant.
Number of study subjects: 200 (half with multifocal and half with accommodating lens implants)
In this study, we will send a secure, online questionnaire to patients who have previously undergone cataract surgery at least two years previously. Patients will receive an email invitation, and by clicking the embedded link and verifying their identity with date of birth and phone number, they will be directed to a survey. The survey will ask the following types of questions:
- overall satisfaction with the surgery
- would they do the same surgery again?
- would they choose the same (elective) lens implant again?
- for what types of activities (reading newspaper, driving, driving at night, fine print) do they require glasses to see clearly?
- do they experience glare and halo symptoms?
- how bothered is the patient by these symptoms?
These data will be stored on a secure server. Statistical analysis will be done by a statistician, using a student's t-test to determine statistical significance of any difference between patients with different types of lens implants.
No intervention will be planned with patients, other than analyzing the survey results. All patient identifying (demographic) information will be carefully protected according to HIPAA and HITECH standards.
- Conditions
- Cataract
- Being tested
- Survey
- Keywords
- cataract satisfaction
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
| Study group | Role | What they receive |
|---|---|---|
| Accommodating Lenses | Patients who underwent surgery with an accommodating lens implant. Receives: Other: Survey | |
| Multifocal Lenses | Patients who underwent surgery with an multifocal lens implant. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction
The patients will be asked to rate their satisfaction with their surgical results on a scale of "very satisfied", "satisfied", "neither satisfied nor dissatisfied", "dissatisfied", or "very dissatisfied".
Measured: At least 24 months after cataract surgery was performed. No upper limit on time since surgery.
Secondary outcomes (1)
Ability to drive without glasses
The patients will be asked to rate their ability to drive without glasses on a scale of "very satisfied", "satisfied", "neither satisfied nor dissatisfied", "dissatisfied", or "very dissatisfied".
Measured: At least 24 months after cataract surgery was performed. No upper limit on time since surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDbackline, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Hovanesian, MD, Principal investigator, MDbackline, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578524
- Sponsor's protocol ID
- BAU141212
- Status last verified
- Oct 2015
- First submitted
- 12 Oct 2015
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction With Multifocal vs Accommodating Lens Implants 2 Years After Surgery
- ClinicalTrials.gov ID
- NCT02578524
- Acronym / sponsor ID
- BAU141212
- Conditions
- Cataract
- Keywords
- cataract satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- MDbackline, LLCUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Oct 2015 (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.
This study will examine patient satisfaction and spectacle independence using a survey in patients who have undergone uncomplicated cataract surgery with a presbyopia-correcting lens at least 2 years prior to administration of the survey.
Detailed description
Purpose: To compare patient-reported satisfaction with a multifocal vs an accommodating presbyopia-correcting at least two years following implantation of either type of implant.
Number of study subjects: 200 (half with multifocal and half with accommodating lens implants)
In this study, we will send a secure, online questionnaire to patients who have previously undergone cataract surgery at least two years previously. Patients will receive an email invitation, and by clicking the embedded link and verifying their identity with date of birth and phone number, they will be directed to a survey. The survey will ask the following types of questions:
- overall satisfaction with the surgery
- would they do the same surgery again?
- would they choose the same (elective) lens implant again?
- for what types of activities (reading newspaper, driving, driving at night, fine print) do they require glasses to see clearly?
- do they experience glare and halo symptoms?
- how bothered is the patient by these symptoms?
These data will be stored on a secure server. Statistical analysis will be done by a statistician, using a student's t-test to determine statistical significance of any difference between patients with different types of lens implants.
No intervention will be planned with patients, other than analyzing the survey results. All patient identifying (demographic) information will be carefully protected according to HIPAA and HITECH standards.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accommodating Lenses | – | Other: SurveyPatients who underwent surgery with an accommodating lens implant. |
| Multifocal Lenses | – | Other: SurveyPatients who underwent surgery with an multifocal lens implant. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent cataract surgery with a multifocal or accommodating lens implant at least two years prior to the survey.
Key inclusion criteria (2 listed)
- Patients with uncomplicated bilateral cataract surgery with either multifocal or accommodating lens implants performed at least 24 months previously
- Patients with or without astigmatic keratotomy or other simultaneous procedures may be included, so long as exclusion criteria are not met.
Key exclusion criteria (3 listed)
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that, in the best judgment of the investigator, could affect their satisfaction with surgery
- Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
- Patients with ≥ grade 1 posterior capsule opacity at their last visit
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 |
|---|---|---|
| Survey | Other | Accommodating Lenses, Multifocal Lenses |
Primary outcome
Satisfaction
Time frame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery.
The patients will be asked to rate their satisfaction with their surgical results on a scale of "very satisfied", "satisfied", "neither satisfied nor dissatisfied", "dissatisfied", or "very dissatisfied".
1 secondary outcome
Ability to drive without glasses
Time frame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery.
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 26 Oct 2015.
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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.
John Hovanesian, MD principal investigator
MDbackline, LLC
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 Cataract, run by MDbackline, LLC 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 2 inclusion and 3 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 26 Oct 2015. 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?
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?
Satisfaction (time frame: At least 24 months after cataract surgery was performed. No upper limit on time since surgery.). 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 26 Oct 2015.