Trial Outcomes & Findings for OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits (NCT NCT01875783)

NCT ID: NCT01875783

Last Updated: 2017-12-22

Results Overview

Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 385 participants
• Primary outcome timeframe: Baseline visit
• Results posted on: 2017-12-22

Participant Flow

Participant milestones

Measure	OCT Imaging All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
Overall Study STARTED	385
Overall Study COMPLETED	385
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

Baseline characteristics by cohort

Measure	OCT Imaging n=385 Participants All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	294 Participants n=93 Participants
Age, Categorical >=65 years	91 Participants n=93 Participants
Age, Continuous	54.8 years STANDARD_DEVIATION 14.1 • n=93 Participants
Sex: Female, Male Female	193 Participants n=93 Participants
Sex: Female, Male Male	192 Participants n=93 Participants
Region of Enrollment United States	385 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline visit

Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm

Outcome measures

Measure

Retina Specialist Care n=385 Participants Percentage of participants who follow-up with a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm as compared with the percentage of patients currently receiving retina eye care (assessed by study participant self-report as well as by determination of historical retina eye care rates from documentation in the medical records of study-eligible patients seen within the previous 6 months)

Rates of Retina Care Referral for Patients With Diabetic Macular Edema

44 Participants

SECONDARY outcome

Timeframe: Baseline visit

Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm

Outcome measures

Measure

Retina Specialist Care n=761 eyes Percentage of participants who follow-up with a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm as compared with the percentage of patients currently receiving retina eye care (assessed by study participant self-report as well as by determination of historical retina eye care rates from documentation in the medical records of study-eligible patients seen within the previous 6 months)

Retinal Referral Rates for Patients With DME

59 eyes

SECONDARY outcome

Timeframe: One month

Population: This is the subgroup of participants who were referred for retinal care by the OCT guided referral algorithm

Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment

Outcome measures

Measure

Retina Specialist Care n=34 Participants Percentage of participants who follow-up with a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm as compared with the percentage of patients currently receiving retina eye care (assessed by study participant self-report as well as by determination of historical retina eye care rates from documentation in the medical records of study-eligible patients seen within the previous 6 months)

Rates of Retinal Treatment for Patients With DME

14 Participants

SECONDARY outcome

Timeframe: 9 months

Population: This is the subgroup of participants who were referred for retina care by the OCT guided referral algorithm.

Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist

Outcome measures

Measure

Retina Specialist Care n=34 Participants Percentage of participants who follow-up with a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm as compared with the percentage of patients currently receiving retina eye care (assessed by study participant self-report as well as by determination of historical retina eye care rates from documentation in the medical records of study-eligible patients seen within the previous 6 months)

Rates of Retinal Treatment Over 1 Year for Patients With DME

18 Participants

Adverse Events

OCT Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Sun

Joslin Diabetes Center

Phone: 617-209-2554

Email: jennifer.sun@joslin.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place