Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)

Cataract Clinical Trial

Official title:

The Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04271709
• Other study ID #: AAAR9162
• Secondary ID: U01DP006436
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: September 29, 2024

Study information

• Verified date: October 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 749
• Est. completion date: September 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blindness
• Cataract
• Diabetic Retinopathy
• Eye Diseases
• Glaucoma
• Vision Impairment and Blindness

Intervention

Behavioral:
• Enhanced Intervention Using Patient Navigators
Enhanced support includes patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.

Other:
• Usual Care
Usual Care subjects who fail the screening and need vision correction will be given an eyeglasses prescription and a list of optical shops within 1 mile from their home. These subjects who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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 — View 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): Suban — View 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. — View 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. — View Citation

Hark LA, Myers JS, Rahmatnejad K, Wang Q, Zhan T, Hegarty SE, Leiby BE, Udyaver S, Waisbourd M, Leite S, Henderer JD, Pasquale LR, Lee PP, Haller JA, Katz LJ. Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Analysis of Unreadable Fundus Images. J Glaucoma. 2018 Nov;27(11):999-1008. doi: 10.1097/IJG.0000000000001082. — View 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. — View 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 Stu — View 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 — View 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. — View 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. — View 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. — View 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. — View 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. 2023 Jul 5:1-9. doi: 10.1080/09286586.2023.2232038. Online ahead o — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects with Visual Acuity Worse than 20/40	Visual acuity (VA) is a measure of the spatial resolution of the visual processing system. Visual acuity will be measured in each eye and measured as =20/40 or >20/40. Since there are two best corrected distance visual acuity measurements per person (right eye and left eye), the visual acuity in the worse eye will be used in the analysis and reported at the patient level, rather than the eye level. Visual acuity analysis will be handled as a dichotomous variable and the proportion of subjects with visual acuity 20/40 or worse will be considered abnormal.	2 years