Screening for Glaucoma in Adults - 1 of 2

Project Summary Title and Description

Title
Screening for Glaucoma in Adults - 1 of 2
Description
Structured Abstract Background: In 2013, the United States Preventive Services Task Force (USPSTF) concluded that the evidence was insufficient to assess the balance of benefits and harms of screening for primary open angle glaucoma in adults (I Statement). Although the USPSTF found that treatment of increased intraocular pressure (IOP) and early glaucoma reduces progression of visual field defects, it found inadequate evidence on the effects of treatment on the development of impaired vision or quality of life. There was no direct evidence on benefits and harms of glaucoma screening versus no screening. Purpose: To systematically review the evidence on screening and treatment of glaucoma for populations and settings relevant to primary care in the United States. Data Sources: We searched the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and MEDLINE (through February 9, 2021), reviewed the studies in the prior reports, and manually reviewed reference lists. Study Selection: Randomized controlled trials (RCTs) of screening and referral; studies on diagnostic accuracy of currently utilized screening tests (optical coherence tomography [OCT], optic disc photography, ophthalmoscopy and biomicroscopy, pachymetry, tonometry, and visual fields); and RCTs of medical therapy versus placebo or no treatment, recently approved medical therapies versus older therapies, and selective laser trabeculoplasty versus medical therapy. Data Extraction: One investigator abstracted data and a second checked accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): A total of 83 studies (N=76,807) were included in this review (30 trials, and 53 diagnostic accuracy studies). Sixteen studies were carried forward from the prior review and 67 studies were new. One RCT (n=616) found vision screening (including components for glaucoma) by an optometrist was associated with no difference in visual acuity or vision-related quality of life compared with no screening, but greater risk of falls (likelihood of at least 1 fall 65% vs. 50%, relative risk [RR] 1.31, 95% confidence interval [CI] 1.13 to 1.50). No study evaluated effects of referral to an eye health provider versus no referral on vision or other health outcomes. Evidence on accuracy of screening tests for identifying persons with glaucoma was most robust for spectral domain-OCT retinal nerve fiber layer thickness (15 studies, N=4,242, sensitivity 0.79, 95% CI 0.74 to 0.84 and specificity 0.91, 95% CI 0.85 to 0.95), area under the receiver operating characteristic curve (16 studies, N=4,060) 0.90, 95% CI 0.86 to 0.93 and spectral domain-OCT ganglion cell analysis (nine studies, N=1,522, sensitivity 0.72, 95% CI 0.64 to 0.78 and specificity 0.91, 95% CI 0.79 to 0.96), tonometry (13 studies, N=32,892, sensitivity 0.46, 95% CI 0.29 to 0.65 and specificity 0.94, 95% CI 0.89 to 0.97), and the Humphrey Visual Field Analyzer (seven studies, N=11,426, sensitivity 0.87, 95% CI 0.73 to 0.94 and specificity 0.78, 95% CI 0.57 to 0.91). Evidence on other screening tests (swept source-OCT, optic disc photography, ophthalmoscopy and biomicroscopy, and pachymetry) was limited. A pilot study and followup found telemedicine screening in primary care associated with variable sensitivity for identifying persons with glaucoma but high specificity. Evidence on the accuracy of instruments for identifying patients at higher risk of glaucoma was limited to one study that was of limited applicability to screening because prior diagnosis of glaucoma was one of the key risk factors. Medical therapy for ocular hypertension and untreated glaucoma was associated with greater reduction in IOP (16 trials, N=3,706, mean difference -3.14 millimeters mercury [mm Hg], 95% CI -4.19 to -2.08) decreased likelihood of glaucoma progression (7 trials, N=3,771, RR 0.68, 95% CI 0.49 to 0.96; absolute risk difference -4.2%) and increased risk of ocular adverse events (2 trials, RR 1.21, 95% CI 1.10 to 1.33 and RR 3.52, 95% CI 2.46 to 5.02) versus placebo or no treatment. One trial (n=461) found no differences between medical therapy versus placebo or no treatment in visual acuity, quality of life, or function. Recently approved medical therapies for glaucoma (netarsudil and latanoprostene bunod) were associated with similar or slightly greater reduction in IOP versus older therapies (6 trials, N=3,128), but increased risk of adverse events. Selective laser trabeculoplasty and medical therapy were associated with similar effects on IOP, visual acuity, visual fields, quality of life, and adverse events (4 trials, N=957). Limitations: Excluded non-English language studies; statistical heterogeneity in pooled analyses on effects of medical therapy versus placebo or no treatment on IOP, though inconsistency was in the magnitude (not direction) of benefit; evidence on effects of treatment on visual impairment, quality of life, and function remains very limited; excluded case-control studies of diagnostic accuracy; evaluation of publication bias limited by small numbers of studies and statistical heterogeneity; most head-to-head comparisons excluded. Conclusions: Direct evidence on glaucoma screening versus no screening is limited and showed no benefits on vision-related quality of life or function, and increased risk of falls. Screening tests (OCT, visual field assessment) can identify persons with OAG with reasonable accuracy. Treatment for ocular hypertension or untreated OAG is associated with reduction in IOP and reduced risk of glaucoma progression based on visual fields or optic nerve changes, but limited evidence on the association with visual outcome, quality of life, and function indicates no clear effects.
Attribution
N/A
Authors of Report
Roger Chou, MD Shelley Selph, MD, MPH Ian Blazina, MPH Christina Bougatsos, MPH Rebecca Jungbauer, DrPH Rongwei Fu, PhD Sara Grusing, MPH Daniel Jonas, MD, MPH Shandiz Tehrani, MD, PhD
Methodology description
Systematic Review
PROSPERO
The final research plan, which serves as a protocol, was published on the USPSTF website here: https://www.uspreventiveservicestaskforce.org/uspstf/document/final-research-plan/primary-open-angle-glaucoma-screening
DOI
N/A
Notes
https://www.ncbi.nlm.nih.gov/books/NBK581087/
Funding Source
AHRQ Contract No. HHSA-290-2015-00011-I, Task Order No. 75Q80119F32015

Key Questions

1. Key Question 1. What are the effects of screening for OAG versus no screening on a) IOP, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
2. Key Question 2. What are the harms of screening for OAG versus no screening?
3. Key Question 6. What are the effects of medical treatments for OAG versus placebo or no treatments on a) IOP, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
4. Key Question 7. What are the harms of medical treatments for OAG versus placebo or no treatments?
5. Key Question 8. What are the effects of newly FDA-approved medical treatments (latanoprostene bunod and netarsudil) versus older medical treatments on a) IOP, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
6. Key Question 9. What are the harms of newly FDA-approved medical treatments versus older medical treatments?
7. Key Question 10. What are the effects of laser trabeculoplasty for OAG versus no trabeculoplasty or medical treatment on a) IOP, visual field loss, visual acuity, or optic nerve damage or b) visual impairment, quality of life, or function?
8. Key Question 11. What are the harms of laser trabeculoplasty for OAG versus no trabeculoplasty or medical treatment?

Associated Extraction Forms

Type
Standard

Associated Studies (each link opens a new tab)

Title Authors Year
Levobunolol. A three-month efficacy study in the treatment of glaucoma and ocular hypertension. Bensinger R E, Keates E U, Gofman J D, Novack G D, Duzman E 1985
Dorzolamide and ocular blood flow in previously untreated glaucoma patients: a controlled double-masked study. Bergstrand Ingar C, Heijl Anders, Harris Alon 2002
The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Kass Michael A, Heuer Dale K, Higginbotham Eve J, Johnson Chris A, Keltner John L, Miller J Philip, Parrish Richard K, Wilson M Roy, Gordon Mae O 2002
Acute versus chronic effects of brimonidine on aqueous humor dynamics in ocular hypertensive patients. Toris C B, Camras C B, Yablonski M E 1999
Ocular hypertension: a follow-up study in treated and untreated patients Ravalico, G., Salvetat, L., Toffoli, G. 1994
Ocular hypertension: correlation of anterior chamber angle width and risk of progression to glaucoma. Wishart P K, Batterbury M 1992
A comparison of treated and untreated glaucoma suspects. Schulzer M, Drance S M, Douglas G R 1991
A long-term clinical trial of timolol therapy versus no treatment in the management of glaucoma suspects. Epstein D L, Krug J H, Hertzmark E, Remis L L, Edelstein D J 1989
Topical timolol administration reduces the incidence of glaucomatous damage in ocular hypertensive individuals. A randomized, double-masked, long-term clinical trial. Kass M A, Gordon M O, Hoff M R, Parkinson J M, Kolker A E, Hart W M, Becker B 1989
Four-week safety and efficacy study of dorzolamide, a novel, active topical carbonic anhydrase inhibitor. Wilkerson M, Cyrlin M, Lippa E A, Esposito D, Deasy D, Panebianco D, Fazio R, Yablonski M, Shields M B 1993
Decrease of optic disc cupping and pallor of ocular hypertensives with timolol therapy. Schwartz B, Lavin P, Takamoto T, Araujo D F, Smits G 1995
The efficacy and safety of brinzolamide 1% ophthalmic suspension (Azopt) as a primary therapy in patients with open-angle glaucoma or ocular hypertension. Brinzolamide Primary Therapy Study Group. Sall K 2000
Long-term effects of timolol therapy in ocular hypertension: a double-masked, randomised trial. Heijl A, Bengtsson B 2000
The European glaucoma prevention study design and baseline description of the participants. Miglior Stefano, Zeyen Thierry, Pfeiffer Norbert, Cunha-Vaz Jose, Torri Valter, Adamsons Ingrid, European Glaucoma Prevention Study Group 2002
Results of the betaxolol versus placebo treatment trial in ocular hypertension. Kamal Deborah, Garway-Heath David, Ruben Simon, O'Sullivan Fiona, Bunce Catey, Viswanathan Anath, Franks Wendy, Hitchings Roger 2003
Five-year follow up of selective laser trabeculoplasty in Chinese eyes. Lai Jimmy S M, Chua John K H, Tham Clement C Y, Lam Dennis S C 2004
A randomised, prospective study comparing selective laser trabeculoplasty with latanoprost for the control of intraocular pressure in ocular hypertension and open angle glaucoma. Nagar M, Ogunyomade A, O'Brart D P S, Howes F, Marshall J 2005
Vision screening for frail older people: a randomised trial. Swamy B, Cumming R G, Ivers R, Clemson L, Cullen J, Hayes M F, Tanzer M, Mitchell P 2009
Intraocular pressure control and fluctuation: the effect of treatment with selective laser trabeculoplasty. Nagar M, Luhishi E, Shah N 2009
A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Weinreb Robert N, Ong Tuyen, Scassellati Sforzolini Baldo, Vittitow Jason L, Singh Kuldev, Kaufman Paul L, VOYAGER study group 2015
Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Garway-Heath David F, Crabb David P, Bunce Catey, Lascaratos Gerassimos, Amalfitano Francesca, Anand Nitin, Azuara-Blanco Augusto, Bourne Rupert R, Broadway David C, Cunliffe Ian A, Diamond Jeremy P, Fraser Scott G, Ho Tuan A, Martin Keith R, McNaught Andrew I, Negi Anil, Patel Krishna, Russell Richard A, Shah Ameet, Spry Paul G, Suzuki Katsuyoshi, White Edward T, Wormald Richard P, Xing Wen, Zeyen Thierry G 2015
Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The APOLLO Study. Weinreb Robert N, Scassellati Sforzolini Baldo, Vittitow Jason, Liebmann Jeffrey 2016
Comparison of Latanoprostene Bunod 0.024% and Timolol Maleate 0.5% in Open-Angle Glaucoma or Ocular Hypertension: The LUNAR Study. Medeiros Felipe A, Martin Keith R, Peace James, Scassellati Sforzolini Baldo, Vittitow Jason L, Weinreb Robert N 2016
Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings. Weinreb Robert N, Liebmann Jeffrey M, Martin Keith R, Kaufman Paul L, Vittitow Jason L 2018
Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). Serle Janet B, Katz L Jay, McLaurin Eugene, Heah Theresa, Ramirez-Davis Nancy, Usner Dale W, Novack Gary D, Kopczynski Casey C, ROCKET-1 and ROCKET-2 Study Groups 2018
Are Patient Self-Reported Outcome Measures Sensitive Enough to Be Used as End Points in Clinical Trials?: Evidence from the United Kingdom Glaucoma Treatment Study. Jones Lee, Garway-Heath David F, Azuara-Blanco Augusto, Crabb David P, United Kingdom Glaucoma Treatment Study Investigators 2019
Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution: Rho Kinase Elevated IOP Treatment Trial (ROCKET-2). Kahook Malik Y, Serle Janet B, Mah Francis S, Kim Terry, Raizman Michael B, Heah Theresa, Ramirez-Davis Nancy, Kopczynski Casey C, Usner Dale W, Novack Gary D, ROCKET-2 Study Group 2019
Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Gazzard Gus, Konstantakopoulou Evgenia, Garway-Heath David, Garg Anurag, Vickerstaff Victoria, Hunter Rachael, Ambler Gareth, Bunce Catey, Wormald Richard, Nathwani Neil, Barton Keith, Rubin Gary, Buszewicz Marta, LiGHT Trial Study Group 2019
Once-Daily Netarsudil Versus Twice-Daily Timolol in Patients With Elevated Intraocular Pressure: The Randomized Phase 3 ROCKET-4 Study. Khouri Albert S, Serle Janet B, Bacharach Jason, Usner Dale W, Lewis Richard A, Braswell Puiwah, Kopczynski Casey C, Heah Theresa, Rocket-4 Study Group 2019
Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Asrani Sanjay, Bacharach Jason, Holland Edward, McKee Hayley, Sheng Huan, Lewis Richard A, Kopczynski Casey C, Heah Theresa 2020
One Year of Netarsudil and Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Phase 3, Randomized MERCURY-1 Study. Brubaker Jacob W, Teymoorian Savak, Lewis Richard A, Usner Dale, McKee Hayley J, Ramirez Nancy, Kopczynski Casey C, Heah Theresa 2020 Sep - Oct
Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Three-Month Data from a Randomized Phase 3 Trial. Asrani S, Robin AL, Serle JB, Lewis RA, Usner DW, Kopczynski CC, Heah T 2019 Nov

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