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Eye DiseasesIRISRegistryNCT02485847

IRIS Registry: Intelligent Research in Sight Registry

An observational study of Eye Diseases, run by American Academy of Ophthalmology at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Eye Diseases
What is being tested?
Ophthalmology
Type of treatment
Surgery or procedure
How many people
20,000,000 participants
Where
1 siteUnited States
Study dates
Mar 2014to Jan 2100
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • Patients who meet the denominator requirements for each measure.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • American Academy of Opthalmology

    San Francisco, California, 94109

    Andy Khuong, 415-561-8500, irisregistry@aao.org

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions
Eye Diseases
Being tested
Ophthalmology
Keywords
Eye Diseases
Medical subject headings
Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OphthalmologyProcedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 5 years

  2. 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.

    Measured: Up to 5 years

  3. 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.

    Measured: Up to 5 years

  4. 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.

    Measured: Up to 5 years

  5. 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.

    Measured: Up to 5 years

  6. Pneumonia Vaccination Status for Older Adults

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

    Measured: Up to 5 years

  7. 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.

    Measured: Up to 5 years

  8. 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

    Measured: Up to 5 years

  9. 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.

    Measured: Up to 5 years

  10. 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.

    Measured: Up to 5 years

  11. 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

    Measured: Up to 5 years

  12. 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.

    Measured: Up to 5 years

  13. 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.

    Measured: Up to 5 years

  14. 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.

    Measured: Up to 5 years

  15. 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.

    Measured: Up to 5 years

  16. 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.

    Measured: Up to 5 years

  17. 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

    Measured: Up to 5 years

  18. 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.

    Measured: Up to 5 years

  19. 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

    Measured: Up to 5 years

  20. 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.

    Measured: Up to 5 years

  21. 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.

    Measured: Up to 5 years

  22. 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.

    Measured: Up to 5 years

  23. 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.

    Measured: Up to 5 years

  24. 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

    Measured: Up to 5 years

  25. Adult Primary Rhegmatogenous Retinal Detachment Surgery Success Rate

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

    Measured: Up to 5 years

  26. 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

    Measured: Up to 5 years

  27. Cataract Surgery: Difference Between Planned and Final Refraction

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

    Measured: Up to 5 years

  28. 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.

    Measured: Up to 5 years

  29. 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

    Measured: Up to 5 years

  30. 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

    Measured: Up to 5 years

  31. 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

    Measured: Up to 5 years

  32. 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

    Measured: Up to 5 years

  33. 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

    Measured: Up to 5 years

  34. 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

    Measured: Up to 5 years

  35. 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

    Measured: Up to 5 years

  36. 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

    Measured: Up to 5 years

  37. 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

    Measured: Up to 5 years

  38. 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

    Measured: Up to 5 years

  39. 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

    Measured: Up to 5 years

  40. 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

    Measured: Up to 5 years

  41. 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.

    Measured: Up to 5 years

  42. 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

    Measured: Up to 5 years

  43. 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

    Measured: Up to 5 years

  44. 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

    Measured: Up to 5 years

  45. 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

    Measured: Up to 5 years

  46. 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

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2015 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2100 (estimated)
  4. Study completionJan 2100 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20,000,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02485847
Sponsor's protocol ID
IRIS Registry
Acronym
IRISRegistry
Status last verified
Jul 2016
First submitted
22 Jun 2015
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Eye Diseases, run by American Academy of Ophthalmology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andy Khuong (415-561-8500, irisregistry@aao.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Open Angle Glaucoma (POAG): Optic Nerve Evaluation (time frame: Up to 5 years). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.

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