Satisfaction & Spectacle Independence With ReSTOR 2.5 & ReSTOR 3.0 IOLs

NCT03073681 | Completed FDA Device

• 1 other identifier: ALC 2.5/3.0 29576247
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

cataract

Outcome Measures

Primary Outcomes (1)

• 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.

  at least 2 months after surgery

Study Arms (2)

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.

Device: Survey

Interventions

Survey 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.

2.5 and 3.0 add lenses

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with healthy eyes and uncomplicated cataract surgery completed at least 2 months before a questionnaire is conducted.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MDbackline, LLC: lead

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Related Publications (1)

• 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.

  PMID: 17172885 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• John Hovanesian, MD

  MDbackline, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: March 3, 2017
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)