Satisfaction & Spectacle Independence With ReSTOR 2.5 & ReSTOR 3.0 IOLs
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 8/23/2018 |
| Start Date: | March 3, 2017 |
| End Date: | August 17, 2018 |
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.
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.
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historical references.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).
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).
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
