Medications Effect on Lenstar Measurements
The Effects of Dilation Medication on Lenstar Measurements for Cataract Surgery
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2015
CompletedFirst Submitted
Initial submission to the registry
May 16, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2018
CompletedJanuary 25, 2019
January 1, 2019
2.8 years
May 16, 2016
January 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Baseline Lens Power will be compared to Post dilation measurements using Lenstar biometer
One Day
Study Arms (1)
Lenstar Biometry
EXPERIMENTALLenstar 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Candidates for cataract surgery undergoing routine evaluation of cataracts.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University Langone Medical Center
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Ostrovsky, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2016
First Posted
May 23, 2016
Study Start
September 18, 2015
Primary Completion
July 24, 2018
Study Completion
July 24, 2018
Last Updated
January 25, 2019
Record last verified: 2019-01