in progress

Final Research Plan

Impaired Visual Acuity and Glaucoma in Adults: Screening

June 11, 2020

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Screening for Impaired Visual Acuity

The analytic framework depicts the relationship between the Key Questions for the systematic review within the context of the populations, interventions, outcomes, and harms of screening and treatment for impaired visual acuity. The far left of the framework describes the target population as asymptomatic adults 65 years of age and older without known vision impairment. To the right of the population is a line representing the diagnostic accuracy of screening leading to the diagnosis of impaired visual acuity (Key Question 3) and instruments for identifying patients at higher risk of impaired visual acuity (Key Question 4), and an additional arrow indicates potential harms of screening (Key Question 2). A subsequent line and area of the framework leads from the impaired visual acuity diagnosis to outcomes from treatment (Key Questions 5 and 6), specifically improved visual acuity, morbidity, mortality, vision-related quality of life, functional status, and cognition. An additional arrow indicates potential harms of treatment (Key Question 7). An overarching arrow leading from the initial screening population to the outcomes represents the direct effects of screening on outcomes (Key Question 1).

*“Asymptomatic” individuals are defined as those without known impaired visual acuity (based on current corrected vision) who have not sought care for evaluation of vision problems.
Conditions of interest include impaired visual acuity due to uncorrected refractive errors, cataracts, and age-related macular degeneration.
Note: Subpopulations of interest include those defined by age, sex, race/ethnicity, setting (e.g., rural or urban), and functional and cognitive status.
Abbreviation: KQ = key question.

Screening for Glaucoma

The analytic framework depicts the relationship between the Key Questions for the systematic review within the context of the populations, interventions, outcomes, and harms of screening and treatment for glaucoma. The far left of the framework describes the target population as asymptomatic adults without known open-angle glaucoma. To the right of the population is a line representing the diagnostic accuracy of screening leading to the diagnosis of open-angle glaucoma (Key Question 4) and instruments for identify patients at higher risk of open-angle glaucoma (Key Question 5), and an additional arrow indicates potential harms of screening (Key Question 2). A subsequent line and area of the framework leads from the open-angle glaucoma diagnosis to outcomes from treatment (Key Questions 6, 8, and 10), including the intermediate outcomes of intraocular pressure, optic nerve assessment, and visual field assessment, and the health outcomes in a separate box connected by a dotted line of reduced visual impairment and improved patient-reported outcomes. An additional arrow indicates potential harms of treatment (Key Questions 7, 9, and 11). An overarching arrow leading from the initial screening population to both intermediate and health outcomes represents the direct effects of screening (Key Question 1) and referral to an eye health provider (Key Question 3) on those outcomes.

*Includes open-angle glaucoma suspects.
Note: Subpopulations of interest include those defined by age, sex, race/ethnicity, and setting (e.g., rural or urban).
Abbreviation: KQ = Key Question.

Screening for Impaired Visual Acuity

  1. What are the effects of vision screening in asymptomatic older adults versus no screening on visual acuity, morbidity or mortality, general or vision-related quality of life, functional status, or cognition?
  2. What are the harms of vision screening in asymptomatic older adults versus no screening?
  3. What is the diagnostic accuracy of screening for impaired visual acuity due to uncorrected refractive error, cataracts, or age-related macular degeneration?
  4. What is the accuracy of instruments for identifying patients at higher risk of impaired visual acuity due to uncorrected refractive error, cataracts, or age-related macular degeneration?
  5. What are the effects of treatment of wet or dry age-related macular degeneration versus placebo or no treatment on visual acuity, morbidity, mortality, general or vision-related quality of life, functional status, or cognition?
  6. What are the effects of newer (aflibercept or brolucizumab-dbll) versus older vascular endothelial growth factor inhibitors for the treatment of wet age-related macular degeneration on visual acuity, morbidity, mortality, general or vision-related quality of life, functional status, or cognition?
  7. What are the harms of treatment of early impaired visual acuity due to wet or dry age-related macular degeneration?

Screening for Glaucoma

  1. What are the effects of screening for open-angle glaucoma versus no screening on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  2. What are the harms of screening for open-angle glaucoma versus no screening?
  3. What are the effects of referral to an eye health provider versus no referral on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  4. What is the accuracy of screening for diagnosis of open-angle glaucoma?
  5. What is the accuracy of instruments for identifying patients at higher risk of open-angle glaucoma?
  6. What are the effects of medical treatments for open-angle glaucoma versus placebo or no treatments on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  7. What are the harms of medical treatments for open-angle glaucoma versus placebo or no therapy?
  8. What are the effects of newly U.S. Food and Drug Administration (FDA)–approved medical treatments (latanoprostene bunod and netarsudil) versus older medical treatments on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  9. What are the harms of newly FDA-approved medical treatments versus older medical treatments?
  10. What are the effects of laser trabeculoplasty for the treatment of open-angle glaucoma versus no trabeculoplasty or medical treatment on a) intraocular pressure, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
  11. What are the harms of laser trabeculoplasty for the treatment of open-angle glaucoma versus no trabeculoplasty or medical treatment?

Screening for Glaucoma

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the association between changes in intraocular pressure, visual field loss, visual acuity, or optic nerve damage following treatment for open-angle glaucoma and improvement in visual impairment, quality of life, or function, and what is the association between changes in intraocular pressure and visual field loss?

 

 

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.

Screening for Impaired Visual Acuity

  Include Exclude
Definition of Disease Impaired visual acuity due to uncorrected refractive errors, cataracts, or age-related macular degeneration for screening and impaired visual acuity due to age-related macular degeneration for treatment Impaired visual acuity due to other conditions
Populations KQs 1–4: Asymptomatic adults age 65 years and older without known impaired visual acuity (based on current corrected vision) and who have not sought care for evaluation of vision problems

KQs 5–7: Asymptomatic adults with vision impairment (current corrected visual acuity worse than 20/40 but better than 20/200) due to uncorrected refractive errors (myopia, hyperopia, astigmatism, or presbyopia), age-related macular degeneration, or cataracts

KQs 1–4: Persons with known impaired visual acuity based on current corrected vision or those who have sought care for evaluation of vision problems

KQs 5–7: Persons with visual acuity worse than 20/200 or other causes of vision loss

Interventions KQs 1, 2: Vision screening performed in primary care or community-based settings, including multicomponent screening with a distinct vision screening component

KQ 3, 4: Vision screening tests performed in primary care or community-based settings; questions or questionnaires for impaired visual acuity

KQs 5–7: For wet age-related macular degeneration, vascular endothelial growth factor inhibitors (ranibizumab, pegaptanib, aflibercept, brolucizumab-dbll, and bevacizumab); for dry age-related macular degeneration, vitamins and antioxidants

KQs 1, 2: Vision screening performed in eye specialty settings

KQ 3, 4: Diagnostic tests for vision screening performed in eye specialty settings (including funduscopic examination performed by an eye professional and specialized diagnostic testing)

KQs 5–7: Laser photocoagulation, photodynamic therapy, or treatment for uncorrected refractive error and cataracts

Outcomes KQs 1, 2, 5–7: Visual acuity; vision-related quality of life; functional capacity, including ability to drive and driving outcomes; other measures of morbidity; mortality; cognition; harms, including falls and fractures; and other treatment-related harms

KQ 3, 4: Sensitivity, specificity, positive and negative predictive values, areas under the receiver operating curve, and other measures of diagnostic test accuracy

KQs 1, 2, 5–7: Reading speed and other tests of vision function
Setting Settings applicable to the United States and relevant to primary care  
Study Designs KQs 1, 2: RCTs and controlled observational studies comparing vision screening with no screening, delayed screening, or usual care (i.e., targeted screening)

KQ 3, 4: Studies evaluating diagnostic accuracy of a screening question or diagnostic test compared with a reference standard

KQs 5–7: RCTs comparing treatment with no treatment (including sham injection); controlled observational studies will be included if evidence on harms from RCTs trials is insufficient

 
Study Quality Fair- or good-quality studies Poor-quality studies

Abbreviation: RCT=randomized controlled trial.

Screening for Glaucoma

Category Include Exclude
Definition of disease Primary open-angle glaucoma: Glaucoma defined by presence of glaucomatous optic disc changes and retinal nerve fiber layer changes, with or without associated visual field changes or elevated intraocular pressure

Glaucoma suspect: Patients do not meet criteria for glaucoma but have a consistently elevated intraocular pressure, a suspicious appearance of the optic nerve, or visual field abnormalities consistent with glaucoma

 
Populations KQs 1–5: Asymptomatic adults age 40 years and older without visual symptoms

KQs 6–11: Adults with screen-detected, asymptomatic, or early primary open-angle glaucoma

KQs 1–5: Patients with visual symptoms, case-control studies of patients known to have open-angle glaucoma and normal controls

KQs 6–11: Patients with open-angle glaucoma and severe visual field or visual deficits; patients with narrow-angle glaucoma, secondary glaucoma, juvenile glaucoma, or other glaucoma

Interventions KQs 1, 2, 4, 5: Screening with a comprehensive eye examination (as defined in the studies) by an eye health provider; screening tests performed in primary care or applicable to primary care; and instruments for identifying persons at increased risk of open-angle glaucoma

KQ 3: Referral to an eye specialist

KQ 4: Diagnostic tests that are currently used:

  1. Comprehensive eye examination
  2. Ophthalmoscopy, direct and indirect
  3. Optic disc photography, including nondigital and digital monoscopic and stereoscopic photography, and planimetry
  4. Perimetry, including high-pass, motion, flicker perimetry, and yellow and blue perimetry
    1. White-on-white standard automated perimetry, including suprathreshold and threshold (classic Humphrey visual field)
  5. Tonometry, contact and noncontact tonometry
    1. Goldmann applanation tonometer
    2. Noncontact tonometer (air puff)
    3. Tono-Pen
  6. Optical coherence tomography and optical coherence tomography angiography
  7. Fundus photography or computerized imaging of the posterior pole, optic disc, or retinal nerve fiber
  8. Pachymetry, when used in conjunction with another test to diagnose glaucoma
  9. Scanning laser polarimetry
  10. Afferent pupillary defect
  11. Ganglion cell complex measurement  

KQs 6–11:

  • First-line medical treatments (prostaglandin analogues, beta blockers, alpha2 agonists, and carbonic anhydrase inhibitors)
  • Selective laser trabeculoplasty
  • Latanoprostene bunod
  • Netarsudil
KQ 4: Screening tests that are no longer used

KQs 6–11: Second-line medical therapies, surgery, non-FDA–approved therapies, therapies not commonly used as first-line therapy in U.S. practice

Comparisons KQs 1, 2: No screening

KQ 3: No referral

KQs 4, 5: Reference standard for open-angle glaucoma (as defined in the studies)

KQs 6–11: Placebo, no treatment, or first-line medical therapies (for selective laser trabeculoplasty, latanoprostene bunod, and netarsudil)

Comparisons involving second-line medical therapies or surgery
Outcomes KQs 1–3, 6–11: Intraocular pressure, visual field loss, visual acuity, optic nerve damage, visual impairment (defined as visual acuity <20/70 or <20/100), quality of life, function, harms (e.g., eye irritation, corneal abrasion, infection, anterior synechiae, or cataracts)

KQs 4, 5: Measures of diagnostic accuracy

Other (not listed) outcomes
Setting Studies conducted in high-income settings applicable to U.S. practice; includes studies performed in primary care (including use of telemedicine) and specialty settings  
Study Design RCTs of screening and treatment; cohort studies for harms of treatment if RCTs not available; population-based cohort or cross-sectional studies of diagnostic accuracy; high-quality systematic reviews Case series, case reports, case-control studies, and diagnostic accuracy studies using the healthy eye of a person with glaucoma as the control
Study Quality Fair- or good-quality studies Poor-quality studies

Abbreviations: FDA=U.S. Food and Drug Administration; RCT=randomized, controlled trials.

The draft Research Plan was posted on the USPSTF website for public comment from February 13 to March 11, 2020. The USPSTF reviewed the comments and made no changes to the scope or Key Questions, although some edits were made for clarity. The USPSTF revised the inclusion/exclusion criteria to clarify the included and excluded diagnostic tests for glaucoma; tests that are no longer used were excluded.