Medications Effect on Lenstar Measurements

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT02780063
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
34.2
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Lenstar Biometer
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
The Effects of Dilation Medication on Lenstar Measurements for Cataract Surgery
Actual Study Start Date :
Sep 18, 2015
Actual Primary Completion Date :
Jul 24, 2018
Actual Study Completion Date :
Jul 24, 2018

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Baseline Lens Power will be compared to Post dilation measurements using Lenstar biometer [One Day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1New York University Langone Medical CenterNew YorkNew YorkUnited States10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT02780063
Other Study ID Numbers:
  • 15-00908
First Posted:
May 23, 2016
Last Update Posted:
Jan 25, 2019
Last Verified:
Jan 1, 2019
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
Keywords provided by NYU Langone Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2019