Effectiveness of Prism Spectacles in Patients With Age Re... | NCT05437302

Studies
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration

NCT05437302

Sponsor

University of Faisalabad

Status

Completed

Last Update Posted

Jun 29, 2022Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Age-Related Macular Degeneration

Interventions

prism spectacle

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2021Actual

Primary Completion Date

May 31, 2022Actual

Completion Date

May 31, 2022Actual

First Submitted Date

Jun 10, 2022

First Submission Date that Met QC Criteria

Jun 23, 2022

First Posted Date

Jun 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2022

Last Update Posted Date

Jun 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
interventional	Experimental	prism spectacles prescribed	Device: prism spectacle
non interventional	Active Comparator	presbyopia glasses prescribed	Device: prism spectacle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prism spectacle	Device	a prism is dispensed in prescription glasses	interventional non interventional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayesha Kiran	University of Faisalabad	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mehreen		Rawalpindi			Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided