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

Primary Purpose

Glaucoma, Vision Impairment and Blindness, Cataract

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Intervention Using Patient Navigators
Usual Care
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Glaucoma focused on measuring Vision Screening, Follow-up Eye Care, Vulnerable Populations, New York City

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Enhanced Intervention

Usual Care

Arm Description

Consented subjects living in buildings randomized to the Enhanced Intervention arm who fail the screening and need vision correction will receive free eyeglasses, which will be fitted by an optician at the housing building. If they are referred to an ophthalmologist for a follow-up eye exam, they will receive enhanced support with 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.

Consented subjects living in buildings randomized to Usual Care arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2020
Last Updated
July 28, 2023
Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04271709
Brief Title
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
Official Title
The Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Vision Impairment and Blindness, Cataract, Diabetic Retinopathy, Eye Diseases
Keywords
Vision Screening, Follow-up Eye Care, Vulnerable Populations, New York City

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
749 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Intervention
Arm Type
Active Comparator
Arm Description
Consented subjects living in buildings randomized to the Enhanced Intervention arm who fail the screening and need vision correction will receive free eyeglasses, which will be fitted by an optician at the housing building. If they are referred to an ophthalmologist for a follow-up eye exam, they will receive enhanced support with 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.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Consented subjects living in buildings randomized to Usual Care arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Intervention Using Patient Navigators
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Subjects with Visual Acuity Worse than 20/40
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A. Hark, PhD, RD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30180021
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.
Results Reference
background
PubMed Identifier
28689028
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.
Results Reference
background
PubMed Identifier
30449754
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.
Results Reference
background
PubMed Identifier
28655730
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.
Results Reference
background
PubMed Identifier
26950579
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.
Results Reference
background
PubMed Identifier
31120381
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.
Results Reference
background
PubMed Identifier
31721654
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.
Results Reference
background
PubMed Identifier
31836105
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.
Results Reference
background
PubMed Identifier
30946709
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.
Results Reference
background
PubMed Identifier
30770354
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.
Results Reference
background
PubMed Identifier
28673747
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.
Results Reference
background
PubMed Identifier
34014814
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.
Results Reference
background
PubMed Identifier
33428354
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.
Results Reference
result
PubMed Identifier
33492894
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.
Results Reference
result

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

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