Medications Effect on Lenstar Measurements

The Effects of Dilation Medication on Lenstar Measurements for Cataract Surgery

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Other: Lenstar Biometer

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lenstar Biometry; 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.	Other: Lenstar Biometer; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Baseline Lens Power will be compared to Post dilation measurements using Lenstar biometer	One Day

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Ann Ostrovsky, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2015
• Primary Completion (Actual): July 24, 2018
• Study Completion (Actual): July 24, 2018

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Dilation; Ophthalmology; Intraocular
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 15-00908

Drug and device information, study documents

• 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