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National Guideline Clearinghouse (NGC). Guideline summary: Care of the patient with diabetes mellitus In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): cited 1993 (revised 2002 Aug 17; reviewed 2007). Available: http://www.guideline.gov.

Bibliographic Source(s)

• American Optometric Association. Care of the patient with diabetes mellitus. 3rd ed. St. Louis (MO): American Optometric Association; 2002 Aug 17. 60 p. [104 references]

Guideline Status

This is the current release of the guideline.

This guideline updates a previously published version: Care of the patient with diabetes mellitus. 2nd ed. St. Louis (MO): American Optometric Association; 1998. 69 p.

According to the guideline developer this guideline has been reviewed on a biannual basis and is considered to be current. This review process involves updated literature searches of electronic databases and expert panel review of new evidence that has emerged since the original publication date.

Guideline Category

Diagnosis
Evaluation
Management
Prevention

Intended Users

Health Plans
Optometrists

Guideline Objective(s)

• To identify patients with undiagnosed diabetes mellitus (DM)
• To identify patients at risk of vision loss from DM
• To preserve human vision by reducing the risk of vision loss in patients with DM through timely diagnosis and intervention
• To improve the quality of care rendered to patients with DM
• To disseminate information and continue the education of health care practitioners regarding the ocular complications of DM and the availability of vision rehabilitation programs
• To stress availability of visual rehabilitation for those with vision loss from DM through low vision devices and psychosocial support

Target Population

Patients of any age with diabetes mellitus

Interventions and Practices Considered

Diagnosis of Ocular Manifestations of Diabetes Mellitus

1. Patient history
2. Ocular examination
   • Best corrected visual acuity
   • Pupillary reflexes
   • Ocular motility
   • Visual field screening
   • Refraction
   • Biomicroscopy
   • Tonometry
   • Stereoscopic fundus examination with pupillary dilation
3. Supplemental testing
   • Color vision assessment
   • Contrast sensitivity testing
   • Fundus photography or validated retinal imaging
   • Gonioscopy
   • Macular function assessment

Management of Nonretinal Ocular Complications

1. Patient education
2. Specific management strategies based on type of ocular complication.

Management of Retinal Complications

1. Patient education
2. Referral for consultation and/or treatment
3. Scatter laser treatment
4. Focal laser treatment
5. Frequent follow-up evaluations (fundus photography fluorescein angiography)

Major Outcomes Considered

Effectiveness of management interventions to reduce ocular complications of diabetes

Methods Used to Collect/Select Evidence

Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases

Description of Methods used to Collect/Select the Evidence

The guideline developer performed literature searches using the National Library of Medicine's Medline database and the VisionNet database.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Expert Consensus (Committee)

Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence

Review

Description of the Methods Used to Analyze the Evidence

Not applicable

Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

Internal Peer Review

Description of Method of Guideline Validation

The Reference Guide for Clinicians was reviewed by the American Optometric Association (AOA) Clinical Guidelines Coordinating Committee and approved by the AOA Board of Trustees.

Major Recommendations

Diagnosis of Ocular Manifestations of Diabetes Mellitus

The first diagnosis of the patient who is unaware of having a diabetic condition may be based on an eye examination. Ocular examination of a patient suspected of having undiagnosed diabetes mellitus (DM) should include all aspects of a comprehensive eye examination. Particular attention should be paid to the ocular and systemic signs and symptoms of DM as discussed in this section.

Patients with DM need regular eye examinations. The examination should include all aspects of a comprehensive eye examination with supplementary testing as indicated to detect and thoroughly evaluate ocular complications. The frequency of examination is determined on the basis of several factors including the type of DM duration of the disease age of the patient level of patient compliance concurrent medical status and both nonretinal and retinal ocular findings. Due to the risk for progression diabetic retinopathy (DR) during pregnancy a diabetic woman should have a baseline examination prior to a planned pregnancy or early in the first trimester of pregnancy.

Components of patient care discussed in greater detail in the guideline document include the following:

1. Patient history
2. Ocular examination
   • Best corrected visual acuity
   • Pupillary reflexes
   • Ocular motility
   • Visual field screening
   • Refraction
   • Biomicroscopy
   • Tonometry
   • Stereoscopic fundus examination with pupillary dilation
3. Examination technique
4. Supplemental testing
   • Color vision assessment
   • Contrast sensitivity testing
   • Fundus photography or validated retinal imaging
   • Gonioscopy
   • Macular function assessment

Management of Ocular Manifestations of Diabetes Mellitus

Treatment decisions depend upon the extent and severity of the patient's ocular condition.

1. Patients with Undiagnosed Diabetes Mellitus

   Patients suspected of having diabetes mellitus (DM) should be screened for high blood glucose levels. The optometrist should refer the patient to a physician for evaluation or request a fasting blood glucose analysis. Patients with fasting blood glucose values of greater than or equal to 110 mg/dL but less than 126 mg/dL have impaired fasting glucose (IFG) and should be retested. All patients with fasting blood glucose values of 126 mg/dL or greater should be referred to physicians for further evaluation or treatment. Most pregnant women should be screened for glucose intolerance. Because a pregnant patient is usually under medical care her obstetrician should coordinate this examination.

2. Patients with Nonretinal Ocular Complications

   Management of nonretinal ocular complications of diabetes mellitus should be consistent with current recommendations of care for each condition. The management of nonretinal ocular complications of diabetes mellitus is briefly outlined in the following table. Treatment protocols should always include patient education and recommendations for follow-up visits.

Management of Nonretinal Ocular Complications of Diabetes Mellitus

Category	Ocular Complications	Management*
Functional	Tritan color vision loss	Dilated fundus examination to rule out diabetic maculopathy; counseling; low vision evaluation; review of independent living aids as necessary
	Refractive error changes Accommodative dysfunction	Consultation with patient's physician regarding degree of blood glucose control; modification of spectacle prescription as necessary
	Visual field defects	Low vision evaluation; orientation and mobility training as necessary
Extraocular Muscle Anomalies	Mononeuropathies	Neuro-ophthalmology or neurology consultation; temporary prism spectacle prescription as needed; eye patching as indicated
Pupils	Sluggish pupillary reflexes Afferent pupillary defects	Workup to rule out optic neuropathy
Conjunctiva	Bulbar microaneurysms	Monitoring
Tear Film	Dry eye syndrome	Prescription of artificial tears ocular lubricants and other dry eye management techniques; monitoring for corneal complications
Cornea	Reduced corneal sensitivity	Monitoring for abrasions keratitis or other ulcerations
	Basement membrane anomalies recurrent corneal erosions	Prescription of NaCl solution/ointment; artificial tears; patching as necessary
	Descemet's membrane wrinkling	Monitoring
	Endothelial cell changes	Monitoring Note: All corneal injuries should be monitored carefully for secondary infection or evidence of delayed wound healing. This is particularly important in patients who wear contact lenses.
Iris	Depigmentation	Monitoring; routine gonioscopy and tonometry
	Rubeosis iridis (neovascularization on the iris)	Gonioscopy to rule out anterior chamber angle involvement and neovascular glaucoma; dilated fundus examination to search for proliferative retinopathy; referral to retinal specialist for possible laser surgery
Lens	Cataracts	Monitoring of both degree of lens opacification and status of any retinopathy; cataract extraction after careful preoperative retinal evaluation; surgery indicated if adequate visualization of the retina is no longer possible
Vitreous	Hemorrhage	Dilated fundus examination; consultation with retina specialist

*Patient education is an integral part of management for all conditions.

3. Patients with Retinal Complications

   When indicated (generally for levels of moderate nonproliferative diabetic retinopathy [NPDR] or worse any proliferative diabetic retinopathy [PDR] any macular edema neovascularization of the iris or unexplained vision loss) the optometrist should refer the DM patients to an ophthalmologist skilled in treating diseases of the retina or a retina specialist.

   Available treatment options management and follow-up for nonproliferative diabetic retinopathy proliferative diabetic retinopathy and macular edema are discussed in greater detail in the guideline document.

   Patient education is an important component of care because virtually all patients with diabetes mellitus will develop some form of diabetic retinopathy at some point during the course of the disease.

   Diabetic patients who do not have diabetic retinopathy should be reexamined annually. The follow-up examination of patients with diabetic retinopathy should be scheduled in accordance with the clinical trial protocols. The frequency and composition of evaluation and management visits for retinal complications of diabetes mellitus are summarized in the following table:

Frequency and Composition of Evaluation and Management Visits for Retinal Complications of Diabetes Mellitus

	Natural Course Rate to Progression to:			Composition of Follow-Up Evaluations		Management Plan*
Severity of Condition	PDR 1 year	HRC 5 years	Frequency of Follow-Up	Fundus Photography	Fluorescein Angiography	Referral for Consultation and/or Treatment	Scatter Laser Treatment	Focal Laser Treatment
Mild NPDR	5%	15%
No macular edema			12 mos	No	No	Communicate with patient's physician	No	No
Macular edema			4 to 6 mos	Yes	Occ.	Obtain retinal consult in 2 to 4 weeks	No	No
CSME			2 to 4 mos	Yes	Yes	Obtain retinal consult in 2 to 4 weeks	No	Yes
Moderate NPDR	12 to 27%	33%
No macular edema			6 to 8 mos	Yes	No	Communicate with patient's physician	No	No
Macular edema (not CSME)			4 to 6 mos	Yes	Occ.	Obtain retinal consult in 2 to 4 weeks	No	No
CSME			2 to 4 mos	Yes	Yes	Obtain retinal consult in 2 to 4 weeks	No	Yes
Severe NPDR	52%	60 to 75%
No macular edema			3 to 4 mos	Yes	No	Obtain retinal consult in 2 to 4 wks	Rarely**	No
Macular edema (not CSME)			2 to 3 mos	Yes	Occ.	Obtain retinal consult in 2 to 4 wks	Occ. after focal**	Occ.
CSME			2 to 3 mos	Yes	Yes	Obtain retinal consult in 2 to 4 wks	Occ. after focal**	Yes
Non-high-risk PDR		75%
No macular edema			2 to 3 mos	Yes	No	Obtain retinal consult in 2 to 4 wks	Occ.***	No
Macular edema			2 to 3 mos	Yes	Occ.	Obtain retinal consult in 2 to 4 wks	Occ. after focal***	Occ.
CSME			2 to 3 mos	Yes	Yes	Obtain retinal consult in 2 to 4 wks	Occ. after focal***	Yes
High-risk PDR
No macular edema			2 to 3 mos	Yes	No	Obtain retinal consult in 24 to 48 hrs	Yes	No
Macular edema			1 to 2 mos	Yes	Yes	Obtain retinal consult in 24 to 48 hrs	Yes	Usually
CSME			1 to 2 mos	Yes	Yes	Obtain retinal consult in 24 to 48 hrs	Yes	Yes

Abbreviations: CSME clinically significant macular edema; HRC high risk category; NPDR nonproliferative diabetic retinopathy; PDR proliferative diabetic retinopathy; Occ. occasionally

*Patient education and written communication with patient's primary care physician are integral to management of DM.
** Consider scatter laser treatment (PRP) especially if every severe NPDR (see levels of DR) significant medical complication or type 2 DM
*** Consider scatter laser treatment (PRP) especially if moderate PDR (see levels of DR) significant medical complication or type 2 DM

Table copyright L.M. Aiello M.D. Used with permission.

Clinical Algorithm(s)

The following clinical algorithms are provided in the original guideline document:

• Optometric Management of the Patient with Undiagnosed Diabetes Mellitus
• Optometric Management of the Patient with Diagnosed Diabetes Mellitus

Type of Evidence supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Potential Benefits

Until modalities are in place to prevent or cure diabetic retinopathy and other complications of diabetes mellitus emphasis must be placed on identification careful follow-up and timely treatment including laser photocoagulation for patients with diabetic retinopathy and diabetic eye disease. Proper care will result in reduction of personal suffering for those involved and a substantial cost savings for the involved individuals their families and the country as a whole.

Potential Harms

Not stated

Qualifying Statements

• Clinicians should not rely on this Clinical Guideline alone for patient care and management. Please refer to the references and other sources listed in the original guideline for a more detailed analysis and discussion of research and patient care information.
• The components of care described in this guideline are not intended to be all-inclusive; professional judgment and individual patient symptoms and findings may have a significant impact on the nature extent and course of the services provided. The optometrist may delegate some components of care.

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools

Clinical Algorithm

For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.

IOM Care Need

Living with Illness

IOM Domain

Effectiveness
Patient-centeredness

Bibliographic Source(s)

• American Optometric Association. Care of the patient with diabetes mellitus. 3rd ed. St. Louis (MO): American Optometric Association; 2002 Aug 17. 60 p. [104 references]

Adaptation

Not applicable: The guideline was not adapted from another source.

Source(s) of Funding

Funding was provided by the Vision Service Plan (Rancho Cordova California) and its subsidiary Altair Eyewear (Rancho Cordova California)

Guideline Committee

American Optometric Association Consensus Panel on Diabetes

Composition of Group that Authored the Guideline

Members: Larry Alexander OD Chair; Allen Blume OD; Jerry Cavallerano OD PhD; Brian Den Beste OD; Jerry Pederson OD; Lesley L. Walls OD MD (1st and 2nd Editions only)

Center for Vision Care Policy Members: Barry Barresi OD PhD; Mort Soroka MPA PhD; Gary Oliver OD; Claudia A. Perry MLS; Leonard Werner OD

Edited and revised by: Jerry Cavallerano OD PhD (1st 2nd and 3rd Editions); Ramachandiran Cooppan MD (1st 2nd and 3rd Editions); Sven-Eric Bursell PhD (1st Edition)

AOA Clinical Guidelines Coordinating Committee Members: John C. Townsend OD Chair (3rd Edition); John F. Amos OD MS (1st 2nd and 3rd Editions); Kerry L. Beebe OD (1st Edition); Jerry Cavallerano OD PhD (1st Edition); John W. Lahr OD (1st Edition); Thomas L. Lewis OD PhD (2nd Edition); W. Howard McAlister OD MPH (3rd Edition); Stephen C. Miller OD (2nd and 3rd Editions); Michael W. Rouse OD (2nd Edition); Richard L. Wallingford OD (1st Edition)

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

This guideline updates a previously published version: Care of the patient with diabetes mellitus. 2nd ed. St. Louis (MO): American Optometric Association; 1998. 69 p.

According to the guideline developer this guideline has been reviewed on a biannual basis and is considered to be current. This review process involves updated literature searches of electronic databases and expert panel review of new evidence that has emerged since the original publication date.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the American Optometric Association Web site.

Print copies: Available from the American Optometric Association 243 N. Lindbergh Blvd. St. Louis MO 63141-7881.

Availability of Companion Documents

None available

Patient Resources

None available

NGC STATUS

This summary was completed by ECRI on December 2 1999. The information was verified by the guideline developer on January 27 2000. This summary was updated by ECRI on April 16 2004. The information was verified by the guideline developer on May 10 2004.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline which is subject to the guideline developer's copyright restrictions as follows:

Copyright to the original guideline is owned by the American Optometric Association (AOA). NGC users are free to download a single copy for personal use. Reproduction without permission of the AOA is prohibited. Permission requests should be directed to Jeffrey L. Weaver O.D. Director Clinical Care Group American Optometric Association 243 N. Lindbergh Blvd. St. Louis MO 63141; (314) 991-4100 ext. 244; fax: (314) 991-4101; e-mail: JLWeaver@AOA.org.

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