Satisfaction & Spectacle Independence With ReSTOR 2.5 & ReSTOR 3.0 IOLs

NCT ID: NCT03073681

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-03
• Study Completion Date: 2019-05-22

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 These data, which include about 85 patients, will be used as historical references.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).

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this 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.

Survey

Intervention Type: DEVICE

Patients will complete a survey describing their satisfaction with vision after cataract surgery that was performed at least 2 months prior to study enrollment.

Interventions

Survey

Patients will complete a survey describing their satisfaction with vision after cataract surgery that was performed at least 2 months prior to study enrollment.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MDbackline, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Hovanesian, MD

Role: PRINCIPAL_INVESTIGATOR

MDbackline, LLC

Locations

Harvard Eye Associates

Laguna Hills, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17172885 (View on PubMed)

Other Identifiers

ALC 2.5/3.0 29576247

Identifier Type: -

Identifier Source: org_study_id