Age-Related Macular DegenerationNCT05437302
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
A study testing prism spectacle in people with Age-Related Macular Degeneration, run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- prism spectacle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Oct 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- prism spectacle
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prism spectacleDevice
a prism is dispensed in prescription glasses
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | prism spectacles prescribed Receives: Device: prism spectacle |
| non interventional | Active comparator | presbyopia glasses prescribed Receives: Device: prism spectacle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Near and Distance visual acuity are measured in log Mar units.
Measured: Four week
Visual Functional Quality of life (VFQOL)
VFQOL is measured by a validated tool VFQOL-25.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start4 Oct 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehreen tanveer, University of Faisalabad
- Investigators
- Ayesha Kiran, Study director, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437302
- Sponsor's protocol ID
- Ufaisalabad
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05437302
- Acronym / sponsor ID
- Ufaisalabad
- Conditions
- Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Device: prism spectacleprism spectacles prescribed |
| non interventional | Active comparator | Device: prism spectaclepresbyopia glasses prescribed |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prism spectaclea prism is dispensed in prescription glasses | Device | interventional, non interventional |
Primary outcome
Visual Acuity
Time frame: Four week
Near and Distance visual acuity are measured in log Mar units.
Visual Functional Quality of life (VFQOL)
Time frame: Four weeks
VFQOL is measured by a validated tool VFQOL-25.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Kiran study director
University of Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prism spectacle in people with Age-Related Macular Degeneration, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: Four week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.