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Myopia progression in children following one year’s wear of spectacles of novel design

Myopia progression following wear of novel-design spectacles

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCH-10000913
Enrollment
Unknown
Registered
2010-06-25
Start date
2010-07-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Observational group:maximum: 201 observational study (sample size is determined by the number of paritipants who can complete the trial IERP2007-017)

Sponsors

Zhongshan Ophthalmic Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years

Inclusion criteria

Inclusion criteria: (Visit 1) Subjects enrolled in the trial must: 1. Have completed the 12-month visit of IERP2007-017; 2. Give informed consents, and have a parent or guardian who is able to read and comprehend Mandarin and who gives informed consent as demonstrated by signing a record of Informed Consent by parent / guardian, and the subject if able to give their own consent; 3. With "normal" ocular health tests.(Subsequent visits) Subjects invited to attend 6-monthly reviews following the initial visit must: Have only worn single vision spectacles as their form of visual correction since the 12-month visit of IERP2007-017

Exclusion criteria

Exclusion criteria: (Visit 1) Subjects enrolled in the trial must NOT : 1. Have acquired an allergy to, or intolerance to tropicamide or topical anaesthetics; 2. Be currently enrolled in another clinical trial (Subsequent visits) Subjects invited to attend 6-monthly reviews following the initial visit must NOT: 1. Have acquired an allergy to, or intolerance to tropicamide or topical anaesthetics; 2. Have had eye surgery since the IERP2007-017 12-month visit; 3. Have had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids since the IERP2007-017 12-month visit; 4. Have worn bifocal or progressive addition spectacles since the IERP2007-017 12-month visit; 5. Have worn orthokeratology contact lenses since the IERP2007-017 12-month visit; 6. Have current orthoptic treatment or vision training. The Investigator may, at his/her discretion, exclude anyone else if it is believed to be in the subject’s best interests.

Design outcomes

Primary

MeasureTime frame
Change in spherical equivalent refraction and axial length from baseline levels;

Contacts

Public ContactXiang Chen
x.chen@brienholdenvision.org+86 020 87330386

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026