NCT01946581

Brief Summary

Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction among patients who have recently undergone cataract surgery.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

September 12, 2013

Last Update Submit

September 16, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient overall satisfaction post Cataract surgery

    Patient will be given a satisfaction survey based on overall satisfaction: * Motivations for choosing their surgeon and for selecting an IOL choice * Fears that they had before surgery * Degree of spectacle independence for activities, including driving (day and night), watching television, computer use, reading print material, using their mobile phone * Degree of overall satisfaction with vision * Degree to which they notice unexpected side effects (dysphotopsias) * Degree to which they felt informed about any side effects they did experience * Activities for which they would like to see better * Willingness to refer friends for the same surgery * Whether they have already referred friends for the same surgery

    60 plus days Post surgery

Study Arms (1)

Cataract Surgery

Procedure: Cataract Surgery

Interventions

Cataract Surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that have had Cataract Surgery.

You may qualify if:

  • Patients with uncomplicated bilateral cataract surgery with a Tecnis Multifocal or monofocal implant completed at least 60 days before the survey date.
  • Patient with and without astigmatic keratotomy will be included.

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 ≥ grade 1 posterior capsule opacity at their last visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • John Hovanesian, MD

    MD backline

    PRINCIPAL INVESTIGATOR
  • John Hovanesian, MD

    MD Backline

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 19, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations