MyopiaNCT00787579
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
A study testing Bifocal spectacles and Prismatic bifocal spectacles in people with Myopia, run by Essilor International at 1 site in Canada.
Trial summary
1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression. 2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear… Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Bifocal spectacles and Prismatic bifocal spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2003to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 8 to 13 years
- Myopia: -1.00 to -5.00 D
- Myopia progression: at least 0.50 D/yr
- Astigmatism and anisometropia: not more than 1.50 D
- Distance monocular visual acuity: 6/6 or better
- Near monocular visual acuity: 0.4 M or better
- Stereoacuity: not more than 40 sec of arc at 40 cm
Who cannot join
- Strabismus
- Ocular diseases
Trial locations and contacts
1 site in 1 country.
About this study
- To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
- To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
- To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.
- Conditions
- Myopia
- Being tested
- Bifocal spectacles, Prismatic bifocal spectacles
- Keywords
- Myopia, bifocal, children
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifocal spectaclesDevice
+1.50D bifocal spectacles
Prismatic bifocal spectaclesDevice
+1.50D bifocal spectacles combined with 3Δ base-in prisms
| Study group | Role | What they receive |
|---|---|---|
| Bifocal spectacles | Active comparator | Not described Receives: Device: Bifocal spectacles |
| Prismatic bifocals | Active comparator | Not described Receives: Device: Prismatic bifocal spectacles |
| Single vision spectacles | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myopia progression, measured by cycloplegic autorefraction
Measured: Every 6 months
Secondary outcomes (1)
Axial length, measured by A-scan ultrasonography
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startApr 2003
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Queensland University of Technology
- Investigators
- Desmond Cheng, OD, MSc, Principal investigator, Queensland University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787579
- Sponsor's protocol ID
- Essilor
- Status last verified
- Nov 2008
- First submitted
- 4 Nov 2008
- Last updated
- 7 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
PubMed 36809645Cheng D, Woo GC, Drobe B, Schmid KL. Effect of bifocal and prismatic bifocal spectacles on myopia progression in children: three-year results of a randomized clinical trial. JAMA Ophthalmol. 2014 Mar;132(3):258-64. doi: 10.1001/jamaophthalmol.2013.7623.
PubMed 24435660Cheng D, Schmid KL, Woo GC, Drobe B. Randomized trial of effect of bifocal and prismatic bifocal spectacles on myopic progression: two-year results. Arch Ophthalmol. 2010 Jan;128(1):12-9. doi: 10.1001/archophthalmol.2009.332.
PubMed 20065211
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children
- ClinicalTrials.gov ID
- NCT00787579
- Acronym / sponsor ID
- Essilor
- Conditions
- Myopia
- Keywords
- Myopia, bifocal, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Queensland University of Technology
- Study start
- Apr 2003
- Primary completion
- Apr 2008 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
- To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
- To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bifocal spectacles | Active comparator | Device: Bifocal spectacles |
| Prismatic bifocals | Active comparator | Device: Prismatic bifocal spectacles |
| Single vision spectacles | No intervention | – |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age: 8 to 13 years
- Myopia: -1.00 to -5.00 D
- Myopia progression: at least 0.50 D/yr
- Astigmatism and anisometropia: not more than 1.50 D
- Distance monocular visual acuity: 6/6 or better
Key exclusion criteria (2 listed)
- Strabismus
- Ocular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifocal spectacles+1.50D bifocal spectacles | Device | Bifocal spectacles |
| Prismatic bifocal spectacles+1.50D bifocal spectacles combined with 3Δ base-in prisms | Device | Prismatic bifocals |
Primary outcome
Myopia progression, measured by cycloplegic autorefraction
Time frame: Every 6 months
1 secondary outcome
Axial length, measured by A-scan ultrasonography
Time frame: Every 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2008.
- Derived from this study: PubMed 36809645Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
- Derived from this study: PubMed 24435660Cheng D, Woo GC, Drobe B, Schmid KL. Effect of bifocal and prismatic bifocal spectacles on myopia progression in children: three-year results of a randomized clinical trial. JAMA Ophthalmol. 2014 Mar;132(3):258-64. doi: 10.1001/jamaophthalmol.2013.7623.
- Derived from this study: PubMed 20065211Cheng D, Schmid KL, Woo GC, Drobe B. Randomized trial of effect of bifocal and prismatic bifocal spectacles on myopic progression: two-year results. Arch Ophthalmol. 2010 Jan;128(1):12-9. doi: 10.1001/archophthalmol.2009.332.
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Desmond Cheng, OD, MSc principal investigator
Queensland University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifocal spectacles and Prismatic bifocal spectacles in people with Myopia, run by Essilor International at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myopia progression, measured by cycloplegic autorefraction (time frame: Every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00787579, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2008.