NCT04734522

Brief Summary

Non-invasive double-blind randomised comparative study on presbyopic subjects wearing progressive lenses.

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 2020

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

October 19, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

January 15, 2021

Last Update Submit

September 28, 2021

Conditions

Presbyopia

Keywords

presbyopiaprogressive addition lenses

Outcome Measures

Primary Outcomes (1)

  • Evaluate the preference among progressive lens designs

    Evaluate the preference among progressive lens designs through a "First impression questionnaire" after 10-15 minutes of wearing each of the 3 PALs, a "Final satisfaction questionnaire" after 1 week of use of each of the 3 PALs and a "Comparison questionnaire" at the end of the three trial periods of all the three types of PALs.

    Entire study duration (approx. 4 weeks)

Secondary Outcomes (2)

  • Evaluate the adaptability of progressive lens designs.

    Entire study duration (approx. 4 weeks)

  • Evaluate visual performance of progressive lens designs.

    Entire study duration (approx. 4 weeks)

Study Arms (2)

The specified PAL design wearers

EXPERIMENTAL

Subjects who have been already wearing any from specified design type of PAL

Device: Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating

The other PAL design wearers

ACTIVE COMPARATOR

Subjects who have been already wearing any from the other design type of PAL

Device: Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating

Interventions

Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coatingDEVICE

Subjects will be wearing three different PAL designs with different geometries of the optical progression.

The other PAL design wearersThe specified PAL design wearers

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects should be experienced progressive lens designs wearers who have worn their current prescription for at least the last one month.
  • PAL wearers with 14 mm corridor
  • Age: 45 to 70 years old
  • Best Corrected Monocular visual Acuity (decimal) both at distance and near ≥ 1.0;
  • Normal binocular vision at distance \& near:
  • no strabismus on cover test,
  • no fixation disparity (Mallett aligning prism of less than 2Δ horizontally or vertically) at near
  • stereoacuity of 60" or better at near;
  • New prescription (found at visit #1) is in the range:
  • Spherical power: up to +/-6.00;
  • Cylindrical power: minus cylinder ≤ 2.5D;
  • Addition: 1.50-2.50D;
  • Difference in the power (spherical equivalent) between eyes: up to 2.0D
  • Understanding and speaking Italian or English to be able to answer questionnaires
  • Giving a written consent to participate in the study

You may not qualify if:

  • First prescription for progressive lenses.
  • Prescription found during visit#1 varies from current prescription more than 0.50D in any meridian
  • Wearing Single Vision lenses with accommodative support
  • Double vision or prismatic prescription in current glasses;
  • Known ocular disease including strabismus, any pathology, any eye surgeries that may affect visual acuity
  • Use of systemic or ocular medications that are likely to affect vision
  • Balance problem/vertigo problem
  • Concurrent participation in other vision-related research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optics and Optometry of Milano-Bicocca (COMiB), Department of Materials Science - University of Milano-Bicocca

Milan, 20126, Italy

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2021

First Posted

February 2, 2021

Study Start

October 19, 2020

Primary Completion

August 31, 2021

Study Completion

September 20, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

IT(1)