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Prismatic Correction for Improving Near Visual Acuity in Patients With Maculopathy

Primary Purpose

Visual Acuity

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
prismatic glasses
Sponsored by
Al-Shifa Trust Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Visual Acuity

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Diagnosed patients of maculopathy refer to low vision clinic Patients with both genders VA from LogMAR 1.0 to LogMAR 0.3 Exclusion Criteria: Maculopathy patients with other ocular disease VA worsen the LogMAR 1.0 Patients with mental illness and other physical lmitations

Sites / Locations

  • Al Shifa Trust Eye Hospital Rawalpindi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

prism glasses

presbyopic glasses

Arm Description

prisms glasses are advised with ranging of 4prism diopters to 10 prism diopters

simple presbyopia glasses according to age are advised

Outcomes

Primary Outcome Measures

Prismatic Correction for Improving Near Visual Acuity in Patients with Maculopathy
A Per forma/questionnaire is used to document Near visual Acuity with the help of light house Chart to see improvement in visual acuity

Secondary Outcome Measures

Full Information

First Posted
January 25, 2023
Last Updated
February 17, 2023
Sponsor
Al-Shifa Trust Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05747417
Brief Title
Prismatic Correction for Improving Near Visual Acuity in Patients With Maculopathy
Official Title
Prismatic Correction for Improving Near Visual Acuity in Patients With Maculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Shifa Trust Eye Hospital

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
patients with maculopathy reported in low vision clinic are tested for prismatic glasses for near vision. The pre and post visual acuity was recorded.
Detailed Description
Diagnosed patient of maculopathy who was visited in low vision clinic are divided in two groups , one is control group (prescribed simple near vision glasses) and other is interventional group(prescribed prismatic glasses). Both groups were follow up after one month to check the improvement in near visual acuity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Acuity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prism glasses
Arm Type
Experimental
Arm Description
prisms glasses are advised with ranging of 4prism diopters to 10 prism diopters
Arm Title
presbyopic glasses
Arm Type
No Intervention
Arm Description
simple presbyopia glasses according to age are advised
Intervention Type
Other
Intervention Name(s)
prismatic glasses
Intervention Description
prism glasses ranging from 4-10 prism diopters
Primary Outcome Measure Information:
Title
Prismatic Correction for Improving Near Visual Acuity in Patients with Maculopathy
Description
A Per forma/questionnaire is used to document Near visual Acuity with the help of light house Chart to see improvement in visual acuity
Time Frame
7 -8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed patients of maculopathy refer to low vision clinic Patients with both genders VA from LogMAR 1.0 to LogMAR 0.3 Exclusion Criteria: Maculopathy patients with other ocular disease VA worsen the LogMAR 1.0 Patients with mental illness and other physical lmitations
Facility Information:
Facility Name
Al Shifa Trust Eye Hospital Rawalpindi
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prismatic Correction for Improving Near Visual Acuity in Patients With Maculopathy

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