NCT02485847

Brief Summary

The IRIS™ Registry (Intelligent Research in Sight) is the nation's first comprehensive eye disease clinical registry. The American Academy of Ophthalmology is developing it as part of the profession's shared goal of continual improvement in the delivery of eye care.The IRIS Registry will be a centralized system for ophthalmology practices to promote practice innovations and achieve clinical excellence.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20,000,000

participants targeted

Target at P75+ for all trials

Timeline
897mo left

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2014Jan 2100

Study Start

First participant enrolled

March 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
84.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2100

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2100

Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

85.9 years

First QC Date

June 22, 2015

Last Update Submit

July 11, 2016

Conditions

Keywords

Eye Diseases

Outcome Measures

Primary Outcomes (46)

  • Primary Open Angle Glaucoma (POAG): Optic Nerve Evaluation

    This measure is to be reported a minimum of once per reporting period for patients seen during the reporting period. It is anticipated that clinicians who provide the primary management of patients with primary open-angle glaucoma (in either one or both eyes) will submit this measure.

    Up to 5 years

  • Age-Related Macular Degeneration (AMD): Dilated Macular Examination

    This measure is to be reported a minimum of once per reporting period for patients, aged 50 years and older, seen during the reporting period. It is anticipated that clinicians who provide the primary management of patients with age-related macular degeneration (in either one or both eyes) will submit this measure.

    Up to 5 years

  • Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of Retinopathy

    Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed which included documentation of the level of severity of retinopathy and the presence or absence of macular edema during one or more office visits within 12 months.

    Up to 5 years

  • Diabetic Retinopathy: Communication with the Physician Managing On-going Diabetes Care

    Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed with documented communication to the physician who manages the on-going care of the patient with diabetes mellitus regarding the findings of the macular or fundus exam at least once within 12 months.

    Up to 5 years

  • Preventive Care and Screening: Influenza Immunization

    Percentage of patients, aged 6 months and older, seen for a visit between October 1 and March 31 who received an influenza immunization, or who reported previous receipt of an influenza immunization.

    Up to 5 years

  • Pneumonia Vaccination Status for Older Adults

    Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine.

    Up to 5 years

  • Diabetes Mellitus: Dilated Eye Exam in Diabetic Patient

    Percentage of patients aged 18 through 75 years with a diagnosis of diabetes mellitus who had a dilated eye exam.

    Up to 5 years

  • Documentation of Current Medications in the Medical Record

    Percentage of patients aged 18 years and older with a list of current medications (includes prescription, over-the-counter, herbals, vitamin/mineral/dietary nutritional supplements) documented by the provider, including drug name, dosage, frequency and route

    Up to 5 years

  • Melanoma: Continuity of Care - Recall System

    This measure is to be reported a minimum of once per reporting period for melanoma patients seen during the reporting period. It is anticipated that clinicians providing care for patients with melanoma or a history of melanoma will submit this measure.

    Up to 5 years

  • Melanoma: Coordination of Care

    This measure is to be reported at each visit occurring during the reporting period for melanoma patients seen during the reporting period. It is anticipated that clinicians providing care for patients with melanoma will submit this measure.

    Up to 5 years

  • Age-Related Macular Degeneration (AMD): Counseling on Antioxidant Supplement

    Percentage of patients aged 50 years and older with a diagnosis of AMD and/or their caregiver(s) who were counseled within 12 months on the benefits and/or risks of the Age-Related Eye Disease Study (AREDS) formulation for preventing progression of AMD

    Up to 5 years

  • Primary Open-Angle Glaucoma (POAG): Reduction of Intraocular Pressure (IOP) by 15% or Documentation of a Plan of Care

    Percentages of patients aged 18 years and older with a diagnosis of POAG whose glaucoma treatment has not failed (the most recent IOP was reduced by at least 15% from the pre-intervention level) or if the most recent IOP was not reduced by at least 15% from the pre-intervention level, a plan of care was documented within 12 months.

    Up to 5 years

  • Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery

    Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and no significant ocular conditions impacting the visual outcome of surgery and had best-corrected visual acuity of 20/40 or better (distance or near) achieved within 90 days following the cataract surgery.

    Up to 5 years

  • Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional Surgical Procedures

    Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and had any of a specified list of surgical procedures in the 30 days following cataract surgery which would indicate the occurrence of any of the following major complications; retained nuclear fragments, endophthalmitis, dislocated or wrong power intraocular lens, retinal detachment, or wound dehiscence.

    Up to 5 years

  • Melanoma: Overutilization of Imaging Studies in Melanoma

    This measure is to be reported once per reporting period for patients with a current diagnosis of melanoma or a history of melanoma who are seen for an office visit during the reporting period. This measure is intended to reflect the quality of services provided for the primary management of patients with melanoma who have an office visit during the reporting period.

    Up to 5 years

  • Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention

    Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months and who received cessation counseling intervention if identified as a tobacco user.

    Up to 5 years

  • Controlling High Blood Pressure

    Percentage of patients 18 through 85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (\< 140/90 mmHg) during the measurement period

    Up to 5 years

  • Use of High-Risk Medications in the Elderly

    Percentage of patients aged 66 years and older who were ordered high-risk medications. Two rates are reported: 1. Percentage of patients who were ordered at least one high-risk medication. 2. Percentage of patients who were ordered at least two different high-risk medications.

    Up to 5 years

  • Biopsy Follow-Up

    Percentage of patients whose biopsy results have been reviewed and communicated to the primary care/referring physician and patient by the performing physician

    Up to 5 years

  • Improvement in Patient's Visual Function within 90 Days Following Cataract Surgery

    Percentage of patients aged 18 years and older in sample who had cataract surgery and had improvement in visual function achieved within 90 days following the cataract surgery, based on completing a pre-operative and postoperative visual function survey.

    Up to 5 years

  • Patient Satisfaction within 90 Days Following Cataract Surgery

    Percentage of patients aged 18 years and older in sample who had cataract surgery and were satisfied with their care within 90 days following the cataract surgery, based on completion of the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey.

    Up to 5 years

  • Falls: Screening for Future Fall Risk

    Percentage of patients 65 years of age and older who were screened for future fall risk during the measurement period.

    Up to 5 years

  • Closing the Referral Loop: Receipt of Specialist Report

    Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred.

    Up to 5 years

  • Adult Primary Rhegmatogenous Retinal Detachment Repair Success Rate

    Percentage of surgeries for primary rhegmatogenous retinal detachment where the retina remains attached after only one surgery

    Up to 5 years

  • Adult Primary Rhegmatogenous Retinal Detachment Surgery Success Rate

    Percentage of retinal detachment cases achieving flat retinas six months post surgery

    Up to 5 years

  • Cataract Surgery with Intra-Operative Complications (Unplanned Rupture of Posterior Capsule requiring unplanned vitrectomy)

    Rupture of the posterior capsule during anterior segment surgery requiring vitrectomy

    Up to 5 years

  • Cataract Surgery: Difference Between Planned and Final Refraction

    Percentage of patients who achieve planned refraction within +-1,0 D

    Up to 5 years

  • Tobacco Use and Help with Quitting Among Adolescents

    The percentage of adolescents 12 to 20 years of age with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user.

    Up to 5 years

  • Corneal Graft: 20/40 or Better Visual Acuity within 90 Days following Corneal Graft Surgery

    Percentage of corneal graft surgery patients with a visual acuity of 20/40 or greater at 90 days after surgery

    Up to 5 years

  • Open-Angle Glaucoma: Intraocular Pressure Reduction

    Percentage of glaucoma patient visits where their IOP was below a threshold level based on the severity of their diagnosis

    Up to 5 years

  • Open-Angle Glaucoma: Visual Field Progression

    Percentage of eyes, in patients with a diagnosis of glaucoma, with a mean deviation loss of more than 3 decibels from their baseline value

    Up to 5 years

  • Open-Angle Glaucoma: Intraocular Pressure Reduction Following Laser Trabeculoplasty

    Percentage of patients underwent laser trabeculoplasty who had IOP reduced by 20% from their pretreatment level

    Up to 5 years

  • Acquired Involutional Ptosis: Improvement of Marginal Reflex Distance within 90 Days Following Surgery for Acquired Involutional Ptosis

    Percentage of surgical ptosis patients with an improvement of marginal reflex distance postoperatively

    Up to 5 years

  • Acquired Involutional Entropion: Normalization of Eyelid Position within 90 Days Following Surgery for Acquired Involutional Entropion

    Percentage of surgical entropion patients with a postoperative normalized lid position

    Up to 5 years

  • Amblyopia: Improvement of Corrected Interocular Visual Acuity Difference to 2 or fewer Lines

    Percentage of newly diagnosed amblyopic patients with a corrected interocular VA difference of 2 or fewer lines (\< 0.23 logMAR) within 6 months of first diagnosis

    Up to 5 years

  • Surgical Esotropia: Patients with Postoperative Alignment of 15 prism diopters or less

    Percentage of surgical esotropia patients with a postoperative alignment of 15 prism diopters or less

    Up to 5 years

  • Diabetic Retinopathy: Dilated Eye Exam

    Percentage of patients aged 18 years and older with a diagnosis of diabetic retinopathy who had a dilated macular or fundus exam performed which included documentation of the level of severity of retinopathy and the presence or absence of macular edema during one or more office visits within 12 months

    Up to 5 years

  • Exudative Age-Related Macular Degeneration: Loss of Visual Acuity

    Percentage of patients with a diagnosis of nonexudative age-related macular degeneration and taking AREDS supplements with of loss of less than 0.3 logMar of visual acuity within the past 12 months

    Up to 5 years

  • Nonexudative Age-Related Macular Degeneration: Loss of Visual Acuity

    Percentage of patients with nonexudative age-related macular degeneration progressing to exudative age-related macular degeneration over the past 12 months

    Up to 5 years

  • Diabetic Macular Edema: Loss of Visual Acuity

    Percentage of patients with a diagnosis of diabetic macular edema with of loss of less than 0.3 logMar of visual acuity within the past 12 months

    Up to 5 years

  • Rhegmatogenous Retinal Detachment Surgery: Visual acuity improvement within 90 days of surgery

    Percentage of patients who underwent rhegmatogenous retinal detachment surgery and achieved an improvement in their visual acuity from their preoperative level within 90 days of surgery in the treated eye.

    Up to 5 years

  • Rhegmatogenous Retinal Detachment Surgery: Return to the operating room within 90 days of surgery

    Percentage of patients who underwent rhegmatogenous retinal detachment surgery and had a return to the operating room within 90 days

    Up to 5 years

  • Acute Anterior Uveitis: Post-treatment visual acuity

    Percentage of acute anterior uveitis patients with a post-treatment best corrected visual acuity of 20/40 or greater OR patients whose visual acuity had returned to their baseline value prior to onset of uveitis

    Up to 5 years

  • Acute Anterior Uveitis: Post-treatment Grade 0 anterior chamber cells

    Percentage of patients with acute anterior uveitis post-treatment with Grade 0 anterior chamber cells

    Up to 5 years

  • Chronic Anterior Uveitis: Post-treatment visual acuity

    Percentage of chronic anterior uveitis patients with a post-treatment best corrected visual acuity of 20/40 or greater OR patients whose visual acuity had returned to their baseline value prior to onset of uveitis

    Up to 5 years

  • Chronic Anterior Uveitis: Post-treatment Grade 0 anterior chamber cells

    Percentage of patients with chronic anterior uveitis post-treatment with Grade 0 anterior chamber cells

    Up to 5 years

Interventions

OphthalmologyPROCEDURE

A registry of ophthalmic ambulatory encounters which captures essential data elements for continuous quality improvement efforts, enhanced patient care outcomes, and pay for performance programs.

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

To ensure the IRIS Registry infrastructure is properly developed with features and functionalities that meets the needs of ophthalmologists, the IRIS Registry is currently only open to Academy members practicing in the United States and its territories.

You may qualify if:

  • Patients who meet the denominator requirements for each measure.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Academy of Opthalmology

San Francisco, California, 94109, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Flora Lum, MD

    American Academy of Ophthalmology

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 30, 2015

Study Start

March 1, 2014

Primary Completion (Estimated)

January 1, 2100

Study Completion (Estimated)

January 1, 2100

Last Updated

July 12, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations