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Pilocarpine and Brimonidine in Patients With Monofocal Lenses

NCT ID: NCT03825081

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Presbyopia Pseudophakia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Brimonidine, pilocarpine

Intervention Type DRUG

1 drop of pilocarpine (0.5%)

1 drop of brimonidine (0.2%)

Interventions

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Brimonidine, pilocarpine

1 drop of pilocarpine (0.5%)

1 drop of brimonidine (0.2%)

Intervention Type DRUG

Other Intervention Names

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Mirvaso; Alphagan P; Salagen; Isopto Carpine

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Gardiner, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Massachusetts Eye and Ear

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew Gardiner, MD

Role: CONTACT

Phone: 617-573-3202

Email: [email protected]

Facility Contacts

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Marisa Tieger, MD

Role: primary

Other Identifiers

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17-151H

Identifier Type: -

Identifier Source: org_study_id