None listed
Conditions
Brief summary
Background: To test and compare in a masked fashion the efficacy of using a parasympathomimetic drug (3 % Carbachol) and an alpha-2 agonist (0.2 % brimonidine) in both combined and separate forms to create optically beneficial miosis to pharmacologically improve vision in presbyopia. Methods: A prospective, double-masked, randomized, controlled clinical trial. Ten naturally emmetropic and presbyopic subjects between 42 years and 58 years old with an uncorrected distance visual acuity of at least 20/20 in both eyes without additional ocular pathology are eligible for inclusion. All subjects received 3 % carbachol and 0.2 % brimonidine in both combined and separate forms, 3% carbachol alone and 0.2% brimonidine (control) alone in their non-dominant eye in a crossover manner with one week washout between tests. The subjects’ pupil size and both near and distance visual acuities will be evaluated pre- and posttreatment at 1, 2, 4, and 8 hours, by a masked examiner at the same room illumination. Results: Statistically significant improvement in mean near visual acuity (NVA) was achieved in all subjects who received combined 3 % Carbachol and brimonidine in the same formula compared to those received separate forms or Carbachol alone or brimonidine alone (P< 0.0001). Conclusion: Based on the data, the combined solution demonstrated greater efficacy than the other solutions that were tested. Improving the depth of focus by making the pupil small caused statistically significant improvement in near visual acuity, with no change in binocular distance vision.
Interventions
One drop was administrated per application to the on-dominant eye by the primary investigator who is an ophthalmologist. Each participant received three treatments to the non-dominant eye - 3% carbachol and 0.2% brimonidine in both combined and separate forms, carbachol only, and brimonidine only. It is a cross-over trial, so that, the washout period was one week.
Sponsors
Almamoun Abdelkader
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
42 Years to 58 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria were as follows: age between 42 and 58 years, emmetropia [cycloplegic spherical equivalent (SE), +/-0.25 D; astigmatism "equal to" or less than 0.25 D] and binocular uncorrected distance visual acuity "equal to" or greater than 20/20
Exclusion criteria
Exclusion criteria concerned patients with myopia, hyperopia and astigmatism higher than 0.25 diopter as well as those with corneal, lens and vitreous opacities, pupil irregularities, anisocoria, amblyopia, chronic general pathologies and medications that would interact unfavorably with carbachol and brimonidine
Outcome results
None listed