Side Effects of Atropine (SEA) Study
Raktažodžiai
Santrauka
apibūdinimas
Atropine drops are commonly used to dilate the eye and prevent the ability to focus and also slow the progression of nearsightedness. Low concentration (0.01%) atropine slows the progression of myopia 60% to 83% while causing less side effects than high concentration (1.0%) atropine though still showing an effect on pupil size and pupil response.This study is a prospective cohort study in which several objective and subjective measurements will be taken before and after the use of 0.01% atropine for a week to determine the effect of this concentration on 1. vision at distance and near; 2. pupil size; 3. focusing ability, accuracy, and change; 4. symptoms, including subjective vision, headaches, light sensitivity, drop comfort; and 5. pressure in the eye. This will allow us to determine the effect these drops have on the eye and whether or not patients would be willing to use them as a possible preventative treatment for nearsightedness. The investigators expect to find that the drops will not affect vision, will increase pupil size, decrease focusing ability and accuracy (but not clinically meaningfully), cause some light sensitivity, and have no effect on eye pressure. The investigators expect that patients would be willing to use these drops to control nearsightedness even after experiencing the side effects.
Datos
| Paskutinį kartą patikrinta: | 02/29/2020 |
| Pirmasis pateikimas: | 06/26/2018 |
| Numatytas registravimas pateiktas: | 07/17/2018 |
| Pirmas paskelbtas: | 07/18/2018 |
| Paskutinis atnaujinimas pateiktas: | 03/01/2020 |
| Paskutinis atnaujinimas paskelbtas: | 03/03/2020 |
| Faktinė studijų pradžios data: | 07/22/2018 |
| Numatoma pirminio užbaigimo data: | 01/16/2019 |
| Numatoma studijų užbaigimo data: | 01/16/2019 |
Būklė ar liga
Intervencija / gydymas
Drug: One Week Atropine
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: One Week Atropine 0.01% concentration atropine drops | Drug: One Week Atropine One drop of 0.01% concentration atropine in each eye at night for seven days. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 21 Years Į 21 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: -N/A Exclusion Criteria: - Outside of age range - History of accommodative (focusing) issues or therapy |
Rezultatas
Pirminės rezultatų priemonės
1. Diameter of the pupil measured with a Neuroptix Pupillometer [One week after beginning treatment with drops]
2. Visual Acuity with Bailey-Lovie logMAR visual acuity charts [One week after beginning treatment with drops]
Antrinės rezultatų priemonės
1. Eye focusing measured by the closest one can read a letter, focusing accuracy measured by an autorefractor, and ability to change focus from far to near measured by stimulating and relaxing focus of the eyes as many times as possible in one minute. [One week after beginning treatment with drops]
2. Change in subjective assessment of potential side effects by asking the same questions before and after administration of eye drops. [One week after beginning treatment with drops]
3. Change in Intraocular Pressure using a Tonopen [One week after beginning treatment with drops]
