Assessment of Progressive Lens Designs
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

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

Detailed description: 
      Background and rationale:

      Nowadays many different types of progressive addition lenses are available for the correction
      of presbyopia. Progressive addition lenses provide a more natural correction for presbyopic
      people due to a gradual and progressive increase of lens power from far area through the
      intermediate portion to the near area. However, some patients still experience adaptation
      problems.

      The primary purpose of the study is to evaluate the preference, adaptability and visual
      performance of progressive lens designs (up to three designs).

      Study procedures:

      Each participant is required to wear all pairs of spectacles one after another, each pair for
      one week.

      Each participant will be required to visit the optometry clinic (at University of Milano
      Bicocca) three times:

      Visit #1: Screening based on inclusion criteria, Informed Consent Form (ICF) form signing,
      Optometric exam and choice of the frame.

      Subjects who will pass the inclusion/exclusion screening will be asked to sign the ICF and
      enrolled for the optometric exam. Subjects will choose the spectacle frame and all individual
      fitting parameters will be measured for lens' manufacturing.

      Visit #2: Subjects will receive three marked pairs of progressive lenses. The three spectacle
      frames will be adjusted to fit properly on the subject' face. After 10-15 min of wearing of
      the first pair of lenses, each subject will be asked to answer to a questionnaire.

      Visit #3 (last visit): questionnaires should be returned; the last comparison question will
      be answered during this visit, and subject will choose the best pair.

      At the end of the study each participant will be entitled to get one pair of progressive
      lenses available in the market.

      Subject population:

      Presbyopic subjects have been already wearing any progressive additional lens (PAL) designs.

      Number of Subjects:

      40 +/- 2 subjects, the specified PAL design wearers and 40 +/- 2 the other PAL design wearers
      to be enrolled and signed the informed consent form.

      Each subject will be wearing three different PAL designs. Subjects will be asked to choose
      one pair of spectacles (design) which they like the most.

      Randomisation:

      This study adopts a stratified permuted block randomisation to reduce an evaluation bias by
      the wearing sequence and prescriptions. The mean of both eyes' prescriptions is set as a
      single stratification factor.

      Frames:

      Each subject will choose a model of spectacle frame. Three identical frames will be taken for
      each subject.

      Lenses:

        1. Lenses will be produced in EU

        2. Three different lens designs will be tested in the study.
    

Intervention name(s): Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating
Intervention type(s): Device
Intervention description(s): Subjects will be wearing three different PAL designs with different geometries of the optical progression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: presbyopia; progressive addition lenses