An interventional study of frame lens in Myopia, Progressive, sponsored by Tianjin Eye Hospital. Not yet recruiting at 1 site in China. Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Tianjin Eye Hospital · Not applicable, Interventional, and Prevention
To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective, single-centre, randomised, double-blind, controlled, non-inferiority clinical study.
Prior to the trial, subjects signed an informed consent form, screened and qualified subjects were enrolled, and subjects received framed spectacles for correction of myopic refractive error in both eyes, and were fitted with framed spectacles by the investigator according to the standard fitting procedure specified in this protocol. Subjects were randomized to Trial Group A (strong high order aberration group) and Trial Group B (medium high order aberration group) and Control Group (HOYA MiYOSMART).
The index of effectiveness in this clinical trial was to assess the effectiveness of the test group of lenses in slowing the rate of myopia progression by examining the subject's objective optometric values after ciliary muscle paralysis. The basic examination of this clinical trial included slit lamp examination, eye axis examination, fundus examination, corneal topography, best-corrected visual acuity, binocular visual function, refractive status and best-corrected visual acuity after ciliary muscle paralysis, and intraocular pressure measurements, etc. The spectacle fitting was also recorded, as well as the subjective feeling of the subjects when wearing the lenses.
Each subject was followed up for 12 months, and the efficacy and safety of the test product for delaying the progression of myopia was evaluated by the investigator at 1 week ± 1 day (telephone follow-up), 1 month ± 15 days (telephone follow-up), 3 months ± 15 days, 6 months ± 15 days, and 12 months ± 30 days after wearing the lenses.
During the course of this clinical trial, the lenses were replaced due to loss, breakage, change in refraction or poor vision with the lenses, etc., after evaluation by the investigator, and the changes were recorded.
71 studies on the registry are indexed under Myopia, Degenerative; 20 are open to participants now.
This study's planned enrollment of 138 is above the median of 122 across 57 interventional studies indexed under Myopia, Degenerative.
Browse Myopia, Degenerative studies →Tianjin Eye Hospital is the lead sponsor of 52 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Simultaneous myopic defocus and strong higher-order aberrations lenses
Device: frame lens
Both myopic defocus and medium higher-order aberrations lenses
Device: frame lens
HOYA MiYOSMART lenses
Device: frame lens
A randomized block group design was used to randomly assign the included study subjects. The appropriate randomization number and random allocation scheme will be given after enrollment.
Cycloplegic objective refraction
Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan)
Time frame: 12 months
Axial Length
Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan)
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2024; primary completion for May 2026, 24 months later.
Of 30 interventional studies with no phase under Myopia, Degenerative, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 96. This study's planned 24 months is below that.
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This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Tianjin Eye Hospital