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Alpha-2 Adrenergic Agonist

Intervention for Presbyopia

Phase < 1
Waitlist Available
Led By Matthew Gardiner, MD
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study. Men and women between ages 60 years and above with monofocal intraocular lenses bilaterally corrected for distance and +/- 0.5D sphere vision who need only +/- 2.5 D correction for reading. Given the age group selected only post menopausal women will be evaluated.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; hours 1; 3; and 6
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Presbyopia
  • Pseudophakia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; hours 1; 3; and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; hours 1; 3; and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in visual acuity after administration of pilocarpine and brimonidine
Secondary outcome measures
Change in near and distance visual acuity

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,916 Total Patients Enrolled
Matthew Gardiner, MDPrincipal InvestigatorMatthew_Gardiner@meei.harvard.edu

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pilocarpine and Brimonidine in Patients With Monofocal Lenses
2019. "Pilocarpine and Brimonidine in Patients With Monofocal Lenses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03825081.
All > Intraocular Lens
~5 spots leftby Apr 2025
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