Recruiting NA Pre-myopia

New treatment option for Pre-myopia

Official title Evaluation of Contact Lenses and Myopia.

ClinicalTrials.gov ID: NCT07566234

What this study is testing

What it's testing
This study will evaluate the effect of dual focus contact lenses on Myopia prevention.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 8 to 10

You may be able to join if

  • Male and female children aged between 8-10 years inclusive.
  • Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.
  • Astigmatism ≤ -1.00D in both eyes.
  • Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.
  • As applicable (dependent on local requirements), the subject and parent/legal guardian will have read the Informed Assent/Consent, been given an...

You likely can't join if

  • History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1...
  • Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
  • Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive...
  • Ocular or systemic disease that contraindicates contact lens wear.
  • Active allergic conjunctivitis.
  • Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
See the full eligibility criteria
Who can join
  • Male and female children aged between 8-10 years inclusive.
  • Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes.
  • Astigmatism ≤ -1.00D in both eyes.
  • Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR.
  • As applicable (dependent on local requirements), the subject and parent/legal guardian will have read the Informed Assent/Consent, been given an explanation of the study, indicated an understanding and signed the forms.
  • Along with their parent or guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol.
  • Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
  • Agree and able to wear the assigned contact lenses successfully for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is...
  • Be in good general health, based on his/her and parent's/guardian's knowledge.
  • Any history of myopia control interventions with in 1 month must complete a 4-weeks of washout period.
What rules you out
  • History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month)
  • Currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
  • Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
  • Ocular or systemic disease that contraindicates contact lens wear.
  • Active allergic conjunctivitis.
  • Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
  • Keratoconus or an irregular cornea.
  • History of clinically significant binocular vision abnormality or strabismus.
  • Any active anterior segment finding that would contraindicate contact lens wear.
  • The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.

The study team makes the final eligibility decision.

Where it's taking place

  • Shanghai, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 8 years to 10 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.