IRIS Registry: Intelligent Research in Sight Registry

Eye Diseases Clinical Trial

— IRISRegistry  

Official title:

IRIS Registry: Intelligent Research in Sight Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02485847
• Other study ID #: IRIS Registry
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2015
• Last updated: July 11, 2016
• Start date: March 2014
• Est. completion date: January 2100

Study information

• Verified date: July 2016
• Source: American Academy of Ophthalmology
• Contact: Andy Khuong
• Phone: 415-561-8500
• Email: irisregistry[@]aao.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical 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 ophthalmology practices to promote practice innovations and achieve clinical excellence.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000000
• Est. completion date: January 2100
• Est. primary completion date: January 2100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• Patients who meet the denominator requirements for each measure.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Eye Diseases

Intervention

Procedure:
• Ophthalmology
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.

Locations

Country	Name	City	State
United States	American Academy of Opthalmology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
American Academy of Ophthalmology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Adult Primary Rhegmatogenous Retinal Detachment Surgery Success Rate	Percentage of retinal detachment cases achieving flat retinas six months post surgery	Up to 5 years	No
Primary	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	No
Primary	Cataract Surgery: Difference Between Planned and Final Refraction	Percentage of patients who achieve planned refraction within +-1,0 D	Up to 5 years	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

•   IRIS Registry web site