Diseases such as congenital cataract and myopia::To evaluate short-term changes in ocular biometric parameters and visual quality, and the safety profile, following a single instillation of 0.01% atropine in pseudophakic children aged 6–12 years after congenital cataract surgery.
Conditions
Interventions
Atropine Group:0.01% atropine eye drops
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Age (calculated as of the date of screening): 6–12 years; 2.Eligible surgical type: unilateral or bilateral congenital cataract surgery with intraocular lens implantation; 3.Eligible refractive status: refractive error in any IOL eye: SE = +0.75 D, astigmatism > -2.00 D; 4.The child and family are willing to participate in treatment with low-concentration atropine eye drops;
Exclusion criteria
Exclusion criteria: 1.Prior use of low-dose (0.01%) atropine eye drops; 2.Current use or use within the past 3 months of any myopia-control intervention (e.g., myopia-control spectacle lenses such as DIMS/MiYOSMART, soft contact lenses designed for myopia control, or low-intensity single-wavelength red-light therapy); 3.Manifest strabismus; 4.Postoperative pupillary synechiae; 5.Known systemic disorders that may affect safety or participation (e.g., uncontrolled systemic autoimmune disease such as systemic lupus erythematosus; severe cardiovascular disease); diagnosis of glaucoma or glaucoma suspect (e.g., shallow anterior chamber, narrow angles); any contraindication to atropine, including known or suspected hypersensitivity to atropine, belladonna/tropane alkaloids, or formulation excipients. 6.Any other condition that, in the investigator’s judgment, makes the participant unsuitable for the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anterior chamber depth,ACD;Pupil diameter,PD;Object scatter index,OSI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure, IOP;Axial length ,AL;Corneal curvature, CC;Anterior chamber angle ,ACA;Anterior chamber volume,ACV;MTF cut off;Contrast visual acuity,CVA; | — |
Countries
China
Contacts
Public ContactJingjing Chen
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed