Back to resultsEffectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
prism spectacle
Sponsored by
About this trial
This is an interventional supportive care trial for Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Patients having age >50 years with age related macular degeneration.
- Patients of both genders (male and female).
- Participants who will be willing to give informed consent for participation in the study.
Exclusion Criteria:
- Presence of all ocular disease and systemic ocular pathologies able to impair visual function.
- Presence of disorders causing choroidal neovascularization other than age related macular degeneration.
- Patients with mental illness, dementia, and severe physical limitations
Sites / Locations
- Mehreen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
interventional
non interventional
Arm Description
prism spectacles prescribed
presbyopia glasses prescribed
Outcomes
Primary Outcome Measures
Visual Acuity
Near and Distance visual acuity are measured in log Mar units.
Visual Functional Quality of life (VFQOL)
VFQOL is measured by a validated tool VFQOL-25.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05437302
Brief Title
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
Official Title
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Faisalabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study is conducted to determine the effectiveness of prism spectacles in improving visual acuity with age related macular degeneration patients and to assess the improvement in quality of life in patients by using prism spectacles.
Detailed Description
A random sampling technique will be used to allocate patient in interventional and non-interventional group. The diagnosed patients of age-related macular degeneration are assessed for prism spectacles for near vision and prism glasses will be dispensed to the patients. Each subject will be interviewed to fill the Proforma after taking the informed consent. The results of this study will show the effectiveness of prism glasses in patients with age related macular degeneration in their daily routine near work as compared to conventional glasses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interventional
Arm Type
Experimental
Arm Description
prism spectacles prescribed
Arm Title
non interventional
Arm Type
Active Comparator
Arm Description
presbyopia glasses prescribed
Intervention Type
Device
Intervention Name(s)
prism spectacle
Intervention Description
a prism is dispensed in prescription glasses
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Near and Distance visual acuity are measured in log Mar units.
Time Frame
Four week
Title
Visual Functional Quality of life (VFQOL)
Description
VFQOL is measured by a validated tool VFQOL-25.
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients having age >50 years with age related macular degeneration.
Patients of both genders (male and female).
Participants who will be willing to give informed consent for participation in the study.
Exclusion Criteria:
Presence of all ocular disease and systemic ocular pathologies able to impair visual function.
Presence of disorders causing choroidal neovascularization other than age related macular degeneration.
Patients with mental illness, dementia, and severe physical limitations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Kiran
Organizational Affiliation
University of Faisalabad
Official's Role
Study Director
Facility Information:
Facility Name
Mehreen
City
Rawalpindi
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
We'll reach out to this number within 24 hrs