Pilocarpine and Brimonidine in Patients With Monofocal Lenses

Presbyopia Clinical Trial

Official title:

Effectiveness of Pilocarpine and Brimonidine to Improve Near Visual Acuity in Patients With Monofocal Intraocular Lenses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825081
• Other study ID #: 17-151H
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 21, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2019
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Matthew Gardiner, MD
• Phone: 617-573-3202
• Email: Matthew_Gardiner[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 31, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Individuals meeting any of the exclusion criteria at baseline will be excluded from study participation including: allergies to proparacaine, pilocarpine or brimonidine, eye infection or inflammation, glaucoma, retinal tear or retinal disease, eye surgery within the past 30 days, use of eye drops within the last seven days, participated in any other research study within the past 30 days. Patients using contact lenses.

Related Conditions & MeSH terms

• Presbyopia
• Pseudophakia

Intervention

Drug:
• Brimonidine, pilocarpine
1 drop of pilocarpine (0.5%) 1 drop of brimonidine (0.2%)

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline; hour 1
Secondary	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.	baseline; hours 1; 3; and 6