Clinical trial NCT03073681: Satisfaction & Spectacle Independence With ReSTOR 2.5 & ReSTOR 3.0 IOLs
Official title: Patient-Reported Satisfaction and Spectacle Independence With the ReSTOR 2.5 Combined With the ReSTOR 3.0 IOL in Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract
Lead sponsor: MDbackline, LLC
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with healthy eyes and uncomplicated cataract surgery completed at least 2 months before a questionnaire is conducted.

Brief 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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Overall satisfaction with surgery
timeFrame: at least 2 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
Study officials:
affiliation: MDbackline, LLC
name: John Hovanesian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.