- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05437302
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
June 23, 2022 updated by: mehreen tanveer, University of Faisalabad
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rawalpindi, Pakistan
- Mehreen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: interventional
prism spectacles prescribed
|
a prism is dispensed in prescription glasses
|
|
Active Comparator: non interventional
presbyopia glasses prescribed
|
a prism is dispensed in prescription glasses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Acuity
Time Frame: Four week
|
Near and Distance visual acuity are measured in log Mar units.
|
Four week
|
|
Visual Functional Quality of life (VFQOL)
Time Frame: Four weeks
|
VFQOL is measured by a validated tool VFQOL-25.
|
Four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ayesha Kiran, University of Faisalabad
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2021
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
June 10, 2022
First Submitted That Met QC Criteria
June 23, 2022
First Posted (Actual)
June 29, 2022
Study Record Updates
Last Update Posted (Actual)
June 29, 2022
Last Update Submitted That Met QC Criteria
June 23, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ufaisalabad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Age-Related Macular Degeneration
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Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
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Innostellar Biotherapeutics Co.,LtdActive, not recruitingNeovascular Age-Related Macular DegenerationChina
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