CataractNCT01946581
Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses and Cataracts Surgery
An observational study of Cataract, run by MDbackline, LLC at 1 site in United States.
Trial summary
Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction among patients who have recently undergone cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have had Cataract Surgery.
Who may be able to join
- Patients with uncomplicated bilateral cataract surgery with a Tecnis Multifocal or monofocal implant completed at least 60 days before the survey date.
- Patient with and without astigmatic keratotomy will be included.
Who cannot join
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that 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, 1 recruiting
- Recruiting
Harvard Eye Associates
Laguna Hills, California, 92653
John Hovanesian, MD
About this study
Official title: Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses Cataracts Surgery
Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction among patients who have recently undergone cataract surgery.
- Conditions
- Cataract
- Being tested
- Cataract Surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cataract Surgery | Not described Receives: Procedure: Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient overall satisfaction post Cataract surgery
Patient will be given a satisfaction survey based on overall satisfaction:
- Motivations for choosing their surgeon and for selecting an IOL choice
- Fears that they had before surgery
- Degree of spectacle independence for activities, including driving (day and night), watching television, computer use, reading print material, using their mobile phone
- Degree of overall satisfaction with vision
- Degree to which they notice unexpected side effects (dysphotopsias)
- Degree to which they felt informed about any side effects they did experience
- Activities for which they would like to see better
- Willingness to refer friends for the same surgery
- Whether they have already referred friends for the same surgery
Measured: 60 plus days Post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014 (estimated)
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
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MDbackline, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Hovanesian, MD, Principal investigator, MD backlineJohn Hovanesian, MD, Study director, MD Backline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946581
- Sponsor's protocol ID
- JH SAT 2013
- Status last verified
- Sep 2013
- First submitted
- 12 Sep 2013
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses Cataracts Surgery
- ClinicalTrials.gov ID
- NCT01946581
- Acronym / sponsor ID
- JH SAT 2013
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MDbackline, LLCUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (estimated)
- First posted
- 19 Sep 2013 (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.
Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction among patients who have recently undergone cataract surgery.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract Surgery | – | Procedure: Cataract Surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have had Cataract Surgery.
Key inclusion criteria (2 listed)
- Patients with uncomplicated bilateral cataract surgery with a Tecnis Multifocal or monofocal implant completed at least 60 days before the survey date.
- Patient with and without astigmatic keratotomy will be included.
Key exclusion criteria (3 listed)
- Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that 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 |
|---|---|---|
| Cataract Surgery | Procedure or surgery | Cataract Surgery |
Primary outcome
Patient overall satisfaction post Cataract surgery
Time frame: 60 plus days Post surgery
Patient will be given a satisfaction survey based on overall satisfaction: * Motivations for choosing their surgeon and for selecting an IOL choice * Fears that they had before surgery * Degree of spectacle independence for activities, including driving (day and night), watching television, computer use, reading print material, using their mobile phone * Degree of overall satisfaction with vision * Degree to which they notice unexpected side effects (dysphotopsias) * Degree to which they felt informed about any side effects they did experience * Activities for which they would like to see better * Willingness to refer friends for the same surgery * Whether they have already referred friends for the same surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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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
MD backline
John Hovanesian, MD study director
MD Backline
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: status not confirmed, as of the sponsor's last update on 19 Sep 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol Hardy (949-900-5248, research@harvardeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient overall satisfaction post Cataract surgery (time frame: 60 plus days Post 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 19 Sep 2013.