Effects and recovery from daily and alternate-day instillation of various low-dose atropine eye drops

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: Arm 1: Drug Name: Atropine Sulphate Dose: 1 drop of 0.01% atropine sulphate eye drops in each eye Duration: Daily instillation for 7 days (7 doses) in one eye, every other day instillation for 7 days (4 doses) in fellow eye Mode of administration: Topical eye drop instilled directly by subject before bed Adherence Monitoring: Participant compliance diary Arm 2: Drug Name: Atropine Sulphate Dose: 1 drop of 0.05% atropine sulphate eye drops in each eye Duration: Daily instillation for 7 days (7 doses) in one eye, every other day instillation for 7 days (4 doses) in fellow eye Mode of administration: Topical eye drop instilled directly by subject before bed Adherence Monitoring: Participant compliance diary CONDITION: Eye ‐ Diseases / disorders of the eye Eye ‐ Normal eye development and function Myopia; ; Myopia PRIMARY OUTCOME: Change in initial pupil size as measured by a pupillometer[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Change in minimum pupil size as measured by a pupillometer[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] INCLUSION CRITERIA: 1) Normal general and ocular health 2) Adults aged 18‐40 years 3) No allergy to atropine or preservatives 4) No history or risk of glaucoma SECONDARY OUTCOME: Change in amplitude of accomodation as measured by push up tests[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Change in average dilation velocity measured by a pupillometer[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Change in average pupil constriction velocity measured by a pupillometer[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Change in axial length as measured by IOLMaster[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Change in latency of pupil constriction measured by a pupillometer[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Change in maximum pupil constriction velocity measured by a pupillometer[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Change in quality of vision as measured by the Quality of Vision Questionnaire[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Change in refractive error using autorefraction and subjective refraction[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Compliance with drop regimen via diary[4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation] Percentage change in pupil size measured by a pupillometer[Baseline, 4 days after beginning drop instillation, 8 days after beginning drop instillation, 11 days after beginning drop instillation, (if necessary) 15 days after beginning drop instillation]
Epistemonikos ID: d496d21c05345fdf4433ea98dbac1dd0d4cffef5
First added on: Aug 25, 2024