IRIS Registry: Intelligent Research in Sight Registry (IRISRegistry)

July 11, 2016 updated by: American Academy of Ophthalmology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The IRIS Registry is primarily a clinical self-improvement tool. It will allow ophthalmologists to compare their patient outcomes, professional performance and care processes against other ophthalmologists across the country. The IRIS Registry will be able to measure the continuum of care from initial patient contact, through intervention and follow up.

Improve Patient Care - Monitor patient interactions, track interventions, identify and address gaps in quality of care, and measure quality outcomes.

Manage Patient Populations - Proactively manage clinical conditions for entire patient populations by running reports on specific care criteria.

Benchmark Your Practice - Identify practice strengths and weaknesses using the IRIS Registry's ophthalmology-specific clinical data from other practices to compare to the performance and outcomes data of your practice.

Run quality reports on demand - Providing clinician- and practice-level results, plus national results and patient-level detail for all IRIS Registry measures.

Enhance Quality and Practice Efficiency - Use the IRIS Registry data to analyze practice processes and procedures and as a source for fact-based decision-making. Because the IRIS Registry will capture data over time at the individual and practice level, it will help practices efficiently manage patient care and optimize practice resources.

Join a Community of Quality - Become a member of a like-minded community of quality-driven professionals striving to continuously improve patient care. Interact with your peers to create opportunities for sharing quality improvement strategies and broaden your professional network.

Study Type

Observational

Enrollment (Anticipated)

20000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • San Francisco, California, United States, 94109
        • Recruiting
        • American Academy of Opthalmology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • Patients who meet the denominator requirements for each measure.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Open Angle Glaucoma (POAG): Optic Nerve Evaluation
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years

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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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)
Time Frame: Up to 5 years
Rupture of the posterior capsule during anterior segment surgery requiring vitrectomy
Up to 5 years
Cataract Surgery: Difference Between Planned and Final Refraction
Time Frame: Up to 5 years
Percentage of patients who achieve planned refraction within +-1,0 D
Up to 5 years
Tobacco Use and Help with Quitting Among Adolescents
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
Percentage of surgical esotropia patients with a postoperative alignment of 15 prism diopters or less
Up to 5 years
Diabetic Retinopathy: Dilated Eye Exam
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
Percentage of patients with chronic anterior uveitis post-treatment with Grade 0 anterior chamber cells
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Flora Lum, MD, American Academy of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

January 1, 2100

Study Completion (Anticipated)

January 1, 2100

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRIS Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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