Medications Effect on Lenstar Measurements

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

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 Disease	Intervention/Treatment	Phase
Cataract	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

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.

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

	Site	City	State	Country	Postal Code
1	New York University Langone Medical Center	New York	New York	United States	10016

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: Dilation; Intraocular; Ophthalmology
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jan 25, 2019