Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings
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|ClinicalTrials.gov Identifier: NCT03751033|
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: BSS Device: DiscoVisc||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence of DisCoVisc OVD on Intraoperative Aberrometry Readings for Intraocular Lens (IOL) Calculations After Cataract Extraction|
|Actual Study Start Date :||September 7, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: BSS and DisCoVisc
Following lens removal and removal of all OVD from the anterior chamber during cataract surgery, the chamber will be filled with BSS and the main incision hydrated with BSS. Intraoperative aberrometry, using the Optiwave® Refractive Analysis with VerifEye+ (ORA), will be performed, and the results of aphakic refraction and suggested IOL power will be recorded in triplicate. Immediately following, the BSS will be replaced with DisCoVisc; and, triplicate readings will be measured under the same conditions.
Intraoperative aberrometry measurements for BSS will be performed.
Intraoperative aberrometry measurements for DiscoVisc will be performed.
- Differences in aphakic refractive measurements with BSS versus DiscoVisc [ Time Frame: 1 Day ]The differences in spherical equivalents will be evaluated using a nonparametric approach (Friedman chi-square test).
- Difference between suggested IOL power selections with BSS versus DiscoVisc [ Time Frame: 1 Day ]The differences in IOL power will be evaluated using a nonparametric approach (Friedman chi-square test).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751033
|Contact: Jodi Pitcheremail@example.com|
|United States, California|
|Advanced Vision Care||Recruiting|
|Los Angeles, California, United States, 90067|
|Contact: Orly Shiler 310-229-1220 firstname.lastname@example.org|
|Principal Investigator: Nicole Fram, MD|
|United States, Ohio|
|Cleveland Eye Clinic||Recruiting|
|Brecksville, Ohio, United States, 44141|
|Contact: Julie Chicwak 440-526-1974 email@example.com|
|Principal Investigator: William Wiley, MD|
|United States, Utah|
|The Eye Institute of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84107|
|Contact: Laurie Adams 801-263-5735 firstname.lastname@example.org|
|Principal Investigator: Robert Cionni, MD|
|Principal Investigator:||Nicole Fram, MD||Advanced Vision Care|