Clinical trial NCT04271709: Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
Official title: The Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glaucoma
Vision Impairment and Blindness
Cataract
Diabetic Retinopathy
Eye Diseases
Keywords: Vision Screening
Follow-up Eye Care
Vulnerable Populations
New York City
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-02-17
Enrollment: 749
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomization by housing development
Primary purpose: SCREENING

Brief summary: The investigators are conducting a 5-year prospective, 2:1 cluster-randomized controlled trial, funded by the Centers for Disease Control (CDC), which provides vision screenings to underserved New York City residents living in affordable housing buildings in Harlem and Washington Heights.

Detailed description: This study aims to increase engagement, detection and management of glaucoma, vision impairment, cataracts, and other eye diseases in vulnerable populations living in New York City. This study considers disparities by race, ethnicity, gender, geography, and socioeconomic status using innovative approaches such as patient navigators. Individuals over the age of 40 living in New York City Housing Authority (NYCHA) Housing buildings are eligible.

Eligibility criteria: Inclusion Criteria:

* Individuals over age 40
* Living independently in NYCHA housing building or attending DFTA Senior Center
* Willing to answer COVID-19 symptom questions
* Willing to consent for 2 vision screening visits at baseline and 12-month follow-up

Exclusion Criteria:

* Self-reported terminal illness with life expectancy less than 1 year
* Inability to provide informed consent due to dementia or other reasons

Primary outcomes:
measure: Proportion of Subjects with Visual Acuity Worse than 20/40
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Lisa A. Hark, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sapru S, Berktold J, Crews JE, Katz LJ, Hark L, Girkin CA, Owsley C, Francis B, Saaddine JB. Applying RE-AIM to evaluate two community-based programs designed to improve access to eye care for those at high-risk for glaucoma. Eval Program Plann. 2017 Dec;65:40-46. doi: 10.1016/j.evalprogplan.2017.06.006. Epub 2017 Jun 21.
citation: Hark L, Acito M, Adeghate J, Henderer J, Okudolo J, Malik K, Molineaux J, Eburuoh R, Zhan T, Katz LJ. Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Ocular Findings at Two Health Centers. J Health Care Poor Underserved. 2018;29(4):1400-1415. doi: 10.1353/hpu.2018.0103.
citation: Pizzi LT, Waisbourd M, Hark L, Sembhi H, Lee P, Crews JE, Saaddine JB, Steele D, Katz LJ. Costs of a community-based glaucoma detection programme: analysis of the Philadelphia Glaucoma Detection and Treatment Project. Br J Ophthalmol. 2018 Feb;102(2):225-232. doi: 10.1136/bjophthalmol-2016-310078. Epub 2017 Jun 27.
citation: Waisbourd M, Shafa A, Delvadia R, Sembhi H, Molineaux J, Henderer J, Pizzi LT, Myers JS, Hark LA, Katz LJ. Bilateral Same-day Laser Peripheral Iridotomy in the Philadelphia Glaucoma Detection and Treatment Project. J Glaucoma. 2016 Oct;25(10):e821-e825. doi: 10.1097/IJG.0000000000000409.
citation: Hark LA, Radakrishnan A, Madhava M, Anderson-Quinones C, Fudemberg S, Robinson D, Myers JS, Zhan T, Adeghate J, Hegarty S, Leite S, Leiby BE, Stempel S, Katz LJ. Awareness of ocular diagnosis, transportation means, and barriers to ophthalmology follow-up in the Philadelphia Telemedicine Glaucoma Detection and Follow-up Study. Soc Work Health Care. 2019 Aug;58(7):651-664. doi: 10.1080/00981389.2019.1614711. Epub 2019 May 23.
citation: Hark LA, Adeghate J, Katz LJ, Ulas M, Waisbourd M, Maity A, Zhan T, Hegarty S, Leiby BE, Pasquale LR, Leite S, Saaddine JB, Haller JA, Myers JS. Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study: Cataract Classifications Following Eye Screening. Telemed J E Health. 2020 Aug;26(8):992-1000. doi: 10.1089/tmj.2019.0170. Epub 2019 Nov 13.
citation: Adeghate JO, Hark LA, Brown H, Henderer JD, Waisbourd M, Molineaux J, Malik K, Maity A, Chuang D, Donches K, Heres C, Eburuoh R, Schardt M, Yu D, Ramsey F, Myers JS, Katz LJ. Philadelphia glaucoma detection and treatment project: ocular outcomes and adherence to follow-up at a single health centre. Can J Ophthalmol. 2019 Dec;54(6):717-722. doi: 10.1016/j.jcjo.2019.03.003. Epub 2019 Sep 19.
citation: Hark LA, Myers JS, Pasquale LR, Razeghinejad MR, Maity A, Zhan T, Hegarty SE, Leiby BE, Waisbourd M, Burns C, Divers M, Molineaux J, Henderer JD, Haller JA, Katz LJ. Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Intraocular Pressure Measurements Found in a Population at High Risk for Glaucoma. J Glaucoma. 2019 Apr;28(4):294-301. doi: 10.1097/IJG.0000000000001207.
citation: Hark LA, Myers JS, Ines A, Jiang A, Rahmatnejad K, Zhan T, Leiby BE, Hegarty S, Fudemberg SJ, Mantravadi AV, Waisbourd M, Henderer JD, Burns C, Divers M, Molineaux J, Pizzi LT, Murchison AP, Saaddine J, Pasquale LR, Haller JA, Katz LJ. Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: confirmation between eye screening and comprehensive eye examination diagnoses. Br J Ophthalmol. 2019 Dec;103(12):1820-1826. doi: 10.1136/bjophthalmol-2018-313451. Epub 2019 Feb 15.
citation: Hark LA, Katz LJ, Myers JS, Waisbourd M, Johnson D, Pizzi LT, Leiby BE, Fudemberg SJ, Mantravadi AV, Henderer JD, Zhan T, Molineaux J, Doyle V, Divers M, Burns C, Murchison AP, Reber S, Resende A, Bui TDV, Lee J, Crews JE, Saaddine JB, Lee PP, Pasquale LR, Haller JA. Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Methods and Screening Results. Am J Ophthalmol. 2017 Sep;181:114-124. doi: 10.1016/j.ajo.2017.06.024. Epub 2017 Jun 30.
citation: Leiby BE, Hegarty SE, Zhan T, Myers JS, Katz LJ, Haller JA, Waisbourd M, Burns C, Divers M, Molineaux J, Henderer J, Brodowski C, Hark LA. A Randomized Trial to Improve Adherence to Follow-up Eye Examinations Among People With Glaucoma. Prev Chronic Dis. 2021 May 20;18:E52. doi: 10.5888/pcd18.200567.
citation: Newman-Casey PA, Hark LA, Rhodes LA. It Is Time to Rethink Adult Glaucoma Screening Recommendations. J Glaucoma. 2023 Feb 1;32(2):69-71. doi: 10.1097/IJG.0000000000002146. Epub 2022 Nov 25. No abstract available.
citation: De Moraes CG, Hark LA, Saaddine J. Screening and Interventions for Glaucoma and Eye Health Through Telemedicine (SIGHT) Studies. J Glaucoma. 2021 May 1;30(5):369-370. doi: 10.1097/IJG.0000000000001782. No abstract available.
citation: Hark LA, Kresch YS, De Moraes CG, Horowitz JD, Park L, Auran JD, Gorroochurn P, Stempel S, Maruri SC, Stidham EM, Banks AZ, Saaddine JB, Lambert BC, Pizzi LT, Sapru S, Price S, Williams OA, Cioffi GA, Liebmann JM. Manhattan Vision Screening and Follow-up Study in Vulnerable Populations (NYC-SIGHT): Design and Methodology. J Glaucoma. 2021 May 1;30(5):388-394. doi: 10.1097/IJG.0000000000001795.
citation: Hark LA, Lin WV, Hirji S, Gorroochurn P, Horowitz JD, Diamond DF, Park L, Wang Q, Auran JD, Maruri SC, Henriquez DR, Sharma T, Valenzuela I, Liebmann JM, Cioffi GA, Friedman DS, Harizman N. Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT): Subanalysis of Referral to Ophthalmology. Curr Eye Res. 2024 Feb;49(2):197-206. doi: 10.1080/02713683.2023.2269614. Epub 2024 Jan 18.
citation: Horowitz JD, Adeghate JO, Karani R, Henriquez DR, Gorroochurn P, Sharma T, Park L, Wang Q, Diamond DF, Harizman N, Auran JD, Maruri SC, Liebmann JM, Cioffi GA, Hark LA. Manhattan Vision Screening and Follow-Up Study: (NYC-SIGHT)Tele-Retinal Image Findings and Importance of Photography. Telemed J E Health. 2024 Mar;30(3):664-676. doi: 10.1089/tmj.2023.0134. Epub 2023 Sep 1.
citation: Hark LA, Tan CS, Kresch YS, De Moraes CG, Horowitz JD, Park L, Auran JD, Gorroochurn P, Stempel S, Maruri SC, Besagar S, Saaddine JB, Lambert BC, Pizzi LT, Sapru S, Price S, Williams OA, Cioffi GA, Liebmann JM. Manhattan Vision Screening and Follow-Up Study in Vulnerable Populations: 1-Month Feasibility Results. Curr Eye Res. 2021 Oct;46(10):1597-1604. doi: 10.1080/02713683.2021.1905000. Epub 2021 Apr 19.
citation: Hark LA, Horowitz JD, Gorroochurn P, Park L, Wang Q, Diamond DF, Harizman N, Auran JD, Maruri SC, Henriquez DR, Carrion J, Muhire RSM, Kresch YS, Pizzi LT, Jutkowitz E, Sapru S, Sharma T, De Moraes CG, Friedman DS, Liebmann JM, Cioffi GA. Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): Baseline Results and Costs of a Cluster-Randomized Trial. Am J Ophthalmol. 2023 Jul;251:12-23. doi: 10.1016/j.ajo.2023.01.019. Epub 2023 Jan 21.
citation: Sapru S, Price SM, Hark LA, Rhodes LA, Newman-Casey PA. Recruiting Populations at Higher Risk for Glaucoma and Other Eye Diseases Experiencing Eye Health Disparities. Ophthalmic Epidemiol. 2024 Jun;31(3):220-228. doi: 10.1080/09286586.2023.2232038. Epub 2023 Jul 5.
citation: Hark LA, Wang Y, Gorroochurn P, Simon PR, Maruri SC, Henriquez DR, Diamond DF, Horowitz JD, Park L, Wang Q, Auran JD, Carrion J, Friedman DS, Liebmann JL, Cioffi GA, Harizman N. Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): a nested cross-sectional assessment of falls risk within a cluster randomised trial. Br J Ophthalmol. 2024 Nov 22;108(12):1761-1768. doi: 10.1136/bjo-2022-323052.
citation: Hark LA, Gorroochurn P, Tang H, Torres DR, Blackburn B, Maruri SC, Diamond DF, Harizman N, Wang Q, Wang Y, Liebmann JM, Cioffi GA, Horowitz JD, Park L. Improvement in vision-related quality-of-life using the NEI-VFQ-9 over 1-year in the Manhattan Vision Screening and Follow-up Study (NYC-SIGHT). Graefes Arch Clin Exp Ophthalmol. 2025 Jan 15. doi: 10.1007/s00417-024-06727-z. Online ahead of print.
citation: Wang Q, Valenzuela IA, Harizman N, Gorroochurn P, Torres DR, Maruri SC, Diamond DF, Horowitz JD, Friedman DS, De Moraes CG, Cioffi GA, Liebmann JM, Hark LA. Glaucoma Screening and Referral Risk Factors in a High-Risk Population: Follow-Up Study of the Manhattan Vision Screening Study. J Glaucoma. 2025 Mar 1;34(3):164-174. doi: 10.1097/IJG.0000000000002521. Epub 2024 Nov 26.
citation: Diamond DF, Kresch YS, Gorroochurn P, Park L, Horowitz JD, Wang Q, Maruri SC, Henriquez DR, Harizman N, Carrion J, Liebmann JM, Cioffi GA, Hark LA. Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): Vision and refractive error results. Clin Exp Optom. 2025 Mar;108(2):183-190. doi: 10.1080/08164622.2024.2322523. Epub 2024 Mar 7.