NCT06484257

Brief Summary

This study examines how myopia (nearsightedness) and hyperopia (farsightedness) affect the use of progressive addition lenses (PALs) for computer users. PALs offer a range of vision correction within one lens, ideal for presbyopia (age-related near focusing difficulty). We'll compare visual comfort, eye strain, and user preference for PALs between myopic and hyperopic individuals while focusing on computer screens.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 26, 2024

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Acuity

    Assessing visual acuity at different distances, including distance vision (for activities such as viewing the computer screen) and near vision (for reading text on the screen), while wearing progressive addition lenses.

    12 Months

  • Subjective Visual Comfort

    Using standardized questionnaires or subjective ratings from participants to assess their comfort level while using computers with progressive addition lenses.

    12 months

  • Visual Fatigue

    Assessing the level of visual fatigue experienced by participants during or after prolonged computer use with the progressive addition lenses. This could involve subjective ratings of eye strain, tiredness, or discomfort.

    12 months

Study Arms (2)

Myopia

ACTIVE COMPARATOR
Behavioral: Myopia

Hypermetropia

OTHER
Other: Hypermetropia

Interventions

MyopiaBEHAVIORAL

Participants in this arm would receive progressive addition lenses specifically designed to correct myopia. These lenses would typically have a prescription for correcting nearsightedness (myopia) in addition to any other vision corrections needed, such as astigmatism correction and presbyopia. The participants would wear these lenses while using computers according to the study protocol.

Myopia

Participants in this arm would receive progressive addition lenses specifically designed to correct hypermetropia. These lenses would typically have a prescription for correcting farsightedness (hypermetropia) in addition to any other vision corrections needed, such as astigmatism correction and presbyopia. The participants would wear these lenses while using computers according to the study protocol.

Hypermetropia

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The age of Participant will be 40 to 55 years
  • Participant diagnosed with myopia having -0.50 to -3.00DS and astigmatism up to -0.75DC
  • Patient diagnosed with Hypermetropia having +050 to +3.00 DS and Astigmatism up to +0.75DC
  • Presbyopia addition will range from +1.00 to +2.50 DS
  • Participants who have worked more than 4 hours on the computer screen.
  • Participants who will be already progressive users and first-time users.
  • Patients with no Ocular disease.

You may not qualify if:

  • Participants with Pre Presbyopia and above 55 years of age
  • Participants with significant ocular disease.
  • Participants with uncontrolled diabetes and hypertension
  • Participants who will not be willing for PAL,s
  • Participants with more than 0.75 astigmatism
  • Participants with known allergies and sensitivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Keratoconus center, Eye 2 Eye Optometrists, 13 D valencia housing society

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

MyopiaHyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

November 1, 2023

Primary Completion

June 1, 2024

Study Completion

October 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations