CataractNCT03073681
Satisfaction & Spectacle Independence With ReSTOR 2.5 & ReSTOR 3.0 IOLs
An observational study of Cataract, run by MDbackline, LLC at 1 site in United States.
Trial summary
Patients implanted with the ReSTOR 2.5 multifocal IOL in the dominant eye and the ReSTOR 3.0 in the non-dominant eye have overall satisfaction and spectacle independence at least comparable to that with bilateral implantation of the 3.0 add lens. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cataract
- What is being tested?
- Survey
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 22 May 2019
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with healthy eyes and uncomplicated cataract surgery completed at least 2 months before a questionnaire is conducted.
Who may be able to join
- Patients implanted with either a ReSTOR 2.5 or 3.0 multifocal within 24 months of the survey administration.
- Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
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 previous refractive surgery
- 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
Official title: Patient-Reported Satisfaction and Spectacle Independence With the ReSTOR 2.5 Combined With the ReSTOR 3.0 IOL in Cataract Surgery
Patients implanted with the ReSTOR 2.5 multifocal IOL in the dominant eye and the ReSTOR 3.0 in the non-dominant eye have overall satisfaction and spectacle independence at least comparable to that with bilateral implantation of the 3.0 add lens. Glare and haloes and other unwanted visual side effects with this mixed combination of lenses is better than with bilateral 3.0 lenses.
Read the detailed description
Patients desire spectacle independence for a range of distances, including distance, intermediate, and near. The ReSTOR 2.5 multifocal lens has been designed to allow better uncorrected intermediate vision and reduce glare and haloes compared to previous, higher-add models. However, their impact on overall patient satisfaction, glare \& haloes (incidence and impact), and spectacle independence has not been examined with a patient-reported outcome study. Additionally, in clinical practice, many clinicians find that bilateral implantation of ReSTOR 2.5 yields insufficient near vision for about 30% of patients (1). For this reason, many surgeons prefer to implant the ReSTOR 2.5 in one eye (usually the dominant) and the ReSTOR 3.0 in the other eye.
MDbackline is a multi-center patient-reported research engine that has been in use since 2013 for data collection in several patient-reported outcome studies for major industry sponsors. Studies performed with MDbackline have been presented at major meetings and are in press with peer-reviewed journals. The investigators have previously conducted studies of patient satisfaction and spectacle independence with the higher add (3.0) multifocal lens prior to the approval of the ReSTOR 2.5. These data, which include about 85 patients, will be used as historical references. They showed a high degree of satisfaction and spectacle independence but complaints of glare and haloes in as many as 37% of patients ("a fair amount of glare" or more). (2) Since approval of the ReSTOR 2.5, the investigators have clinically observed far fewer complaints of glare/haloes when the lower-add lens is used in at least one eye.
In this study the investigators propose to evaluate patients with the ReSTOR 2.5 lens in one eye and the ReSTOR 3.0 in the other using substantially the same questionnaire in the previous study described above. The investigators plan to compare results of these new data (2.5/3.0 combination) with the previous study data (3.0/3.0).
- Conditions
- Cataract
- Being tested
- Survey
- Keywords
- cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyDevice
Patients will complete a survey describing their satisfaction with vision after cataract surgery that was performed at least 2 months prior to study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Historical controls | This group of historical controls makes up patients who have previously undergone cataract surgery with a 3.0 add ReSTOR lens in each eye. This group has already completed a satisfaction questionnaire identical to what will be posed in the 2.5/3.0 add lens group. | |
| 2.5 and 3.0 add lenses | This group will have undergone cataract surgery at least 2 months before conducting a questionnaire. Patients enrolled in this group had cataract surgery with a 2.5 add ReSTOR lens in one eye and a 3.0 add lens in the other. Receives: Device: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction with surgery
Overall satisfaction with surgery, defined as the percentage of patients who report "top box" (5 out of 5) satisfaction with implantation of a 2.5D add ReSTOR implant in the dominant eye and a 3.0D add ReSTOR implant in the non-dominant eye.
Measured: at least 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start3 Mar 2017
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT03073681
- Sponsor's protocol ID
- ALC 2.5/3.0 29576247
- Status last verified
- Jun 2019
- First submitted
- 3 Mar 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to share IPD.
Publications
Fraunfelder FW. Corneal toxicity from topical ocular and systemic medications. Cornea. 2006 Dec;25(10):1133-8. doi: 10.1097/01.ico.0000240084.27663.fd.
PubMed 17172885
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Satisfaction and Spectacle Independence With the ReSTOR 2.5 Combined With the ReSTOR 3.0 IOL in Cataract Surgery
- ClinicalTrials.gov ID
- NCT03073681
- Acronym / sponsor ID
- ALC 2.5/3.0 29576247
- Conditions
- Cataract
- Keywords
- cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MDbackline, LLCUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 8 Mar 2017 (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.
Patients implanted with the ReSTOR 2.5 multifocal IOL in the dominant eye and the ReSTOR 3.0 in the non-dominant eye have overall satisfaction and spectacle independence at least comparable to that with bilateral implantation of the 3.0 add lens. Glare and haloes and other unwanted visual side effects with this mixed combination of lenses is better than with bilateral 3.0 lenses.
Detailed description
Patients desire spectacle independence for a range of distances, including distance, intermediate, and near. The ReSTOR 2.5 multifocal lens has been designed to allow better uncorrected intermediate vision and reduce glare and haloes compared to previous, higher-add models. However, their impact on overall patient satisfaction, glare \& haloes (incidence and impact), and spectacle independence has not been examined with a patient-reported outcome study. Additionally, in clinical practice, many clinicians find that bilateral implantation of ReSTOR 2.5 yields insufficient near vision for about 30% of patients (1). For this reason, many surgeons prefer to implant the ReSTOR 2.5 in one eye (usually the dominant) and the ReSTOR 3.0 in the other eye.
MDbackline is a multi-center patient-reported research engine that has been in use since 2013 for data collection in several patient-reported outcome studies for major industry sponsors. Studies performed with MDbackline have been presented at major meetings and are in press with peer-reviewed journals. The investigators have previously conducted studies of patient satisfaction and spectacle independence with the higher add (3.0) multifocal lens prior to the approval of the ReSTOR 2.5. These data, which include about 85 patients, will be used as historical references. They showed a high degree of satisfaction and spectacle independence but complaints of glare and haloes in as many as 37% of patients ("a fair amount of glare" or more). (2) Since approval of the ReSTOR 2.5, the investigators have clinically observed far fewer complaints of glare/haloes when the lower-add lens is used in at least one eye.
In this study the investigators propose to evaluate patients with the ReSTOR 2.5 lens in one eye and the ReSTOR 3.0 in the other using substantially the same questionnaire in the previous study described above. The investigators plan to compare results of these new data (2.5/3.0 combination) with the previous study data (3.0/3.0).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Historical controls | – | –This group of historical controls makes up patients who have previously undergone cataract surgery with a 3.0 add ReSTOR lens in each eye. This group has already completed a satisfaction questionnaire identical to what will be posed in the 2.5/3.0 add lens group. |
| 2.5 and 3.0 add lenses | – | Device: SurveyThis group will have undergone cataract surgery at least 2 months before conducting a questionnaire. Patients enrolled in this group had cataract surgery with a 2.5 add ReSTOR lens in one eye and a 3.0 add lens in the other. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with healthy eyes and uncomplicated cataract surgery completed at least 2 months before a questionnaire is conducted.
Key inclusion criteria (2 listed)
- Patients implanted with either a ReSTOR 2.5 or 3.0 multifocal within 24 months of the survey administration.
- Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
Key exclusion criteria (4 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 previous refractive surgery
- 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 |
|---|---|---|
| SurveyPatients will complete a survey describing their satisfaction with vision after cataract surgery that was performed at least 2 months prior to study enrollment. | Device | 2.5 and 3.0 add lenses |
Primary outcome
Overall satisfaction with surgery
Time frame: at least 2 months after surgery
Overall satisfaction with surgery, defined as the percentage of patients who report "top box" (5 out of 5) satisfaction with implantation of a 2.5D add ReSTOR implant in the dominant eye and a 3.0D add ReSTOR implant in the non-dominant eye.
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 5 Jun 2019.
- Background: PubMed 17172885Fraunfelder FW. Corneal toxicity from topical ocular and systemic medications. Cornea. 2006 Dec;25(10):1133-8. doi: 10.1097/01.ico.0000240084.27663.fd.
- Individual participant dataSharing planned: No. We do not plan to share IPD.
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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 4 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 5 Jun 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?
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?
Overall satisfaction with surgery (time frame: at least 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073681, which also lists 1 linked publication.
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 5 Jun 2019.