NCT06914076

Brief Summary

Vision impairments affect 2.2 billion people worldwide, including 36 million who are blind and 217 million with moderate-to-severe visual impairment. In the US, age-related vision loss is a leading cause of disability among older adults.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Low Vision

Outcome Measures

Primary Outcomes (2)

  • DASS 21

    The DASS-21 uses the following categories to interpret scores: Normal: 0-9 (Depression), 0-7 (Anxiety), 0-14 (Stress) Mild: 10-13 (Depression), 8-9 (Anxiety), 15-18 (Stress) Moderate: 14-20 (Depression), 10-14 (Anxiety), 19-25 (Stress) Severe: 21-27 (Depression), 15-19 (Anxiety), 26-33 (Stress) Extremely Severe: 28+ (Depression), 20+ (Anxiety), 34+ (Stress)

    12 Months

  • LVQoL Questionare

    Total Score Interpretation: * 25-50: Good quality of life * 51-75: Moderate quality of life * 76-100: Poor quality of life * 101-125: Very poor quality of life

    12 Months

Study Arms (2)

Structured Psychosocial Counseling

EXPERIMENTAL
Combination Product: Structured Psychosocial Counseling

Standard Care

ACTIVE COMPARATOR
Diagnostic Test: Standard Care

Interventions

Structured Psychosocial CounselingCOMBINATION_PRODUCT

"Group A (Experimental Group): Participants in the Experimental group will be divided into groups with the persons having visual acuity 6/60, counting fingers and light perception will receive low vision aids etc and structured psychosocial counseling tailored for individuals with low vision. Counseling will be delivered over a 12-week period, consisting of weekly 60-minute sessions conducted by trained counselors. The program will focus on the following: Coping mechanisms for depression and anxiety. Strategies to improve functional independence and daily living skills. Social integration techniques to enhance participation in community activities. Low visions aids under supervision of low vision specialist."

Structured Psychosocial Counseling
Standard CareDIAGNOSTIC_TEST

Group B (Control Group): The control group will continue receiving standard care, including referrals and informational support.

Standard Care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 18 to 80 years.
  • Both male and female
  • Individuals diagnosed with low vision, defined as a visual acuity of less than 6/18 but equal to or better than 3/60 in the better eye with best correction.
  • Individuals having visual acuity 6/60, Counting fingers or light perception.
  • Individuals experiencing symptoms of depression or anxiety as assessed through a validated screening tool.
  • Individuals reporting reduced functional independence in daily activities due to low vision.

You may not qualify if:

  • Unable to provide informed consent.
  • Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder, or severe post-traumatic stress disorder.
  • Existing involvement in similar counseling programs.
  • Presence of medical conditions or disabilities.
  • Pregnant individuals if pregnancy-related complications or responsibilities could interfere with participation in the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dial hospital, Qadirabad road Ali pur chattah

Gujranwala, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)