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Medications Effect on Lenstar Measurements

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lenstar Biometer
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cataract focused on measuring Dilation, Intraocular, Ophthalmology

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Candidates for cataract surgery undergoing routine evaluation of cataracts.

Exclusion Criteria:

  • Patients that have had their cataracts removed
  • Patients that cannot undergo routine evaluation for cataract surgery (because they are too ill to sit upright in a chair)

Sites / Locations

  • New York University Langone Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenstar Biometry

Arm Description

Lenstar biometry will be performed on each eye prior to dilation. Subjects eyes will be dilated and subject will wait 20 minutes. Lenstar biometry will be performed after the 20 wait time.

Outcomes

Primary Outcome Measures

Baseline Lens Power will be compared to Post dilation measurements using Lenstar biometer

Secondary Outcome Measures

Full Information

First Posted
May 16, 2016
Last Updated
January 24, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02780063
Brief Title
Medications Effect on Lenstar Measurements
Official Title
The Effects of Dilation Medication on Lenstar Measurements for Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2015 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
July 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prior to cataract surgery the lens must be calculated to appropriately fit a patient for the intraocular lens implant. Lenstar is an optical biometer that calculates the axial length, keratometry, lens thickness, pupillometry, and anterior chamber depth. Dilation drops are routinely used in eye exams in addition to pre-cataract surgery. The dilation drops include Tropicamide 1%, and Phenylephrine 2.5%. The Tropicamide achieves the dilation of the pupil which causes an anterior rotation of the ciliary body, which may affect the Lenstar measurements. This study is to determine if dilating medications affect the lens power prediction for emmetropia by the Lenstar biometer. Prior to dilation, Lenstar biometry will be performed on each eye. Patients will receive dilation medication and after waiting 20 minutes Lenstar biometry will be performed on each eye. Dilation and measurement with Lenstar will be done as standard of care. Measurements and calculations from before and after will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Dilation, Intraocular, Ophthalmology

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenstar Biometry
Arm Type
Experimental
Arm Description
Lenstar biometry will be performed on each eye prior to dilation. Subjects eyes will be dilated and subject will wait 20 minutes. Lenstar biometry will be performed after the 20 wait time.
Intervention Type
Other
Intervention Name(s)
Lenstar Biometer
Intervention Description
uses optical principles (laser interferometry) to measure axial length, measuring distance from the corneal apex to the retinal RPE. In addition to axial length, it also measures corneal thickness, anterior chamber depth, lens thickness, radii of curvature of flat and steep meridian, axis of flat meridian, white to white distance, and pupil diameter.
Primary Outcome Measure Information:
Title
Baseline Lens Power will be compared to Post dilation measurements using Lenstar biometer
Time Frame
One Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Candidates for cataract surgery undergoing routine evaluation of cataracts. Exclusion Criteria: Patients that have had their cataracts removed Patients that cannot undergo routine evaluation for cataract surgery (because they are too ill to sit upright in a chair)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Ostrovsky, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Medications Effect on Lenstar Measurements

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