NCT05437302

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 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

October 4, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 10, 2022

Last Update Submit

June 23, 2022

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

  • Visual Acuity

    Near and Distance visual acuity are measured in log Mar units.

    Four week

  • Visual Functional Quality of life (VFQOL)

    VFQOL is measured by a validated tool VFQOL-25.

    Four weeks

Study Arms (2)

interventional

EXPERIMENTAL

prism spectacles prescribed

Device: prism spectacle

non interventional

ACTIVE COMPARATOR

presbyopia glasses prescribed

Device: prism spectacle

Interventions

prism spectacleDEVICE

a prism is dispensed in prescription glasses

interventionalnon interventional

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehreen

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Ayesha Kiran

    University of Faisalabad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 29, 2022

Study Start

October 4, 2021

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)