An Early Phase 1 interventional study of Brimonidine, pilocarpine in Presbyopia and Pseudophakia, sponsored by Massachusetts Eye and Ear Infirmary. Status unknown at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by Massachusetts Eye and Ear Infirmary · Early Phase 1, Interventional, and Treatment
The current study aims to assess the use of pilocarpine and brimonidine to improve near visual acuity in patietns with monofocal intraocular lenses. Thirty-three subjects with be enrolled and baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.
This research study will try to find out if pilocarpine and brimonidine can help people with intraocular lens implants read without reading glasses. Thirty-three subjects will take part in this research study. Baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.All subjects will take part at Massachusetts Eye and Ear Infirmary (MEEI).
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's planned enrollment of 33 is below the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
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Exclusion Criteria:
Interventions will be the drugs: * pilocarpine - 0.5% * brimonidine - 0.2% One drop of each of the study drugs will be placed in the non-dominant eye and patient will be evaluated for adverse events. At hour 1 and 3 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured and patient will be evaluated for adverse events. At hour 6 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured; patient will be evaluated for adverse events; and quality of life/satisfaction survey (NEI RQL-42) will be given to patient.
Drug: Brimonidine, pilocarpine
Drug pages: Brimonidine · Pilocarpine
1 drop of pilocarpine (0.5%) 1 drop of brimonidine (0.2%)
Also known as: Mirvaso; Alphagan P; Salagen; Isopto Carpine
Change in visual acuity after administration of pilocarpine and brimonidine
The primary aim of our study is to determine if the combination of pilocarpine and brimonidine improves near visual acuity in pseudophakic subjects 1 hour following drop placement, compared to baseline.
Time frame: baseline; hour 1
Change in near and distance visual acuity
Near visual acuity at 3 hours and 6 hours, distance visual acuity at 1,3, and 6 hours.
Time frame: baseline; hours 1; 3; and 6
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Brimonidine · Pilocarpine
Massachusetts Eye and Ear Infirmary →