NCT00223756

Brief Summary

The primary purpose of this research study is to evaluate the effectiveness of a new outpatient low vision rehabilitation program that is targeted to serve legally blind veterans with central vision loss. The hypothesis is that veterans in the treatment group will self-report less difficulty performing daily activities than veterans in the control group who are on a waiting list for VA low vision or blind rehabilitation programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

January 6, 2016

Conditions

Vision, Low

Keywords

Vision, Low

Outcome Measures

Primary Outcomes (1)

  • VA LV VFQ-48 Reading Domain Scores

    4 months from baseline

Study Arms (2)

Arm 1

EXPERIMENTAL

interdisciplinary, outpatient blind rehabilitation

Other: Low Vision Intervention - Outpatient Training Program

Arm 2

NO INTERVENTION

usual care

Interventions

Low Vision Intervention - Outpatient Training ProgramOTHER

Patients receive LV therapy as outpatients

Also known as: Therapy Group
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary eye diagnosis (in better seeing eye) of either macular degeneration, macular dystrophy, macular hole or inflammatory disease of the macula
  • Habitual visual acuity (in better seeing eye) better than 20/500 but less than 20/100

You may not qualify if:

  • does not have a phone
  • does not speak English
  • has previously received low vision services as part of an inpatient blind rehabilitation program
  • has participated in a low vision program that provided low vision devices to meet reading needs with low vision therapy administered by an occupational therapist or vision rehabilitation professional since most recent significant decrease in vision
  • has English literacy less than 5th grade level
  • has habitual visual acuity in better seeing eye of equal to or better than 20/100, less than or equal to 20/500
  • fails Telephone Interview of Cognitive Status (TICS) screening (score of 30 or lower)
  • has history of stroke with aphasia
  • has other health condition that would preclude follow-up (e.g. significant malignancy or life-threatening disease)
  • is unable or unwilling to attend clinic visits required for the study
  • has severe hearing impairment that interferes with participation in telephone questionnaires
  • reports significant loss of vision since last eye exam
  • has vitreous hemorrhage, serous or hemorrhagic detachment of the macula, clinically significant macular edema or cystoid macular edema that is likely to result in further loss or improvement in vision after treatment in better seeing eye
  • plans cataract extraction in the next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

Related Publications (3)

  • Stroupe KT, Stelmack JA, Tang XC, Reda DJ, Moran D, Rinne S, Mancil R, Wei Y, Cummings R, Mancil G, Ellis N, Massof RW. Economic evaluation of blind rehabilitation for veterans with macular diseases in the Department of Veterans Affairs. Ophthalmic Epidemiol. 2008 Mar-Apr;15(2):84-91. doi: 10.1080/09286580802027836.

    PMID: 18432491RESULT

  • Stelmack JA, Tang XC, Reda DJ, Rinne S, Mancil RM, Massof RW; LOVIT Study Group. Outcomes of the Veterans Affairs Low Vision Intervention Trial (LOVIT). Arch Ophthalmol. 2008 May;126(5):608-17. doi: 10.1001/archopht.126.5.608.

    PMID: 18474769RESULT

  • Stelmack JA, Tang XC, Reda DJ, Moran D, Rinne S, Mancil RM, Cummings R, Mancil G, Stroupe K, Ellis N, Massof RW. The Veterans Affairs Low Vision Intervention Trial (LOVIT): design and methodology. Clin Trials. 2007;4(6):650-60. doi: 10.1177/1740774507085274.

    PMID: 18042574RESULT

MeSH Terms

Conditions

Vision, Low

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joan Stelmack, OD MPH

    Edward Hines Jr. VA Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

November 1, 2004

Primary Completion

July 1, 2006

Study Completion

August 1, 2007

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

US(1)