NCT05747417

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

January 25, 2023

Last Update Submit

February 17, 2023

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

  • 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

    7 -8 months

Study Arms (2)

prism glasses

EXPERIMENTAL

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

Other: prismatic glasses

presbyopic glasses

NO INTERVENTION

simple presbyopia glasses according to age are advised

Interventions

prismatic glassesOTHER

prism glasses ranging from 4-10 prism diopters

prism glasses

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed patients of maculopathy refer to low vision clinic
  • Patients with both genders
  • VA from LogMAR 1.0 to LogMAR 0.3

You may not qualify if:

  • Maculopathy patients with other ocular disease
  • VA worsen the LogMAR 1.0
  • Patients with mental illness and other physical lmitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Shifa Trust Eye Hospital Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager Light House

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 28, 2023

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)