Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings

Completed · Not applicable

Conditions studied: Cataract

In brief

The purpose of the study is to develop a nomogram that correlates intraoperative, aphakic refraction measurements when the anterior chamber is pressurized with either balanced salt solution (BSS) or DisCoVisc; and to understand how suggested IOL power selection may differ.

Key facts

Study ID

NCT03751033

Run by

Clinical Research Consultants, Inc.

People needed

120

Starts

2018-09-07

Expected to finish

2020-01-06

Last updated by the study team

2020-04-21

Who can join

Age: 22 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In good general health
• Between 22 and 95 years of age and diagnosed with cataract(s)
• Able to comprehend and sign a written statement of informed consent for participation in the study, including HIPAA
• Undergoing cataract extraction surgery with an Alcon SN6 platform intraocular lens implantation into the posterior chamber
• Clear intraocular media, other than cataract
• Potential postoperative best-corrected visual acuity (BSCVA) of 20/30 or better
• Axial length of ≥ 22.00 and ≤ 28.00

You may not qualify if…

• Concurrent participation in another investigational drug or device study or participation in another study within the last 30 days prior to Screening
• Has had prior laser vision correction and/or corneal surgery
• Has a complication during surgery unrelated to ORA use
• Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma or posterior capsule defects
• History of infectious corneal disease (e.g., herpes simplex, herpes zoster, etc.) or other conditions which may result in corneal scarring
• Significant central opacity/scar
• Irregular astigmatism based upon investigator judgment
• Inability to achieve keratometric stability
• Will require another procedure, such as iris hooks, use of a Malyugin ring or insertion of a capsular tension ring during surgery
• Will require significant sedation during surgery
• Subject who is unable to maintain adequate fixation for image capture with ORA
• Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism, including, but not limited to the following: corneal leukoma and pterygium
• Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
• May reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy)
• Amblyopia
• Corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
• Endothelial disease that may potentially affect visual outcome
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 20/30 and/or that the investigator deems would interfere with acquiring images or determining a precise postoperative refraction
• Shallow anterior chamber, not due to swollen cataract
• History of retinal detachment or macular pucker
• Ocular conditions such as keratoconus, forme fruste keratoconus or recurrent erosion syndrome that may predispose the subject to complications
• Microphthalmos
• Previous corneal transplant
• Recurrent severe anterior or posterior segment inflammation of unknown etiology
• Rubella or traumatic cataract

Where it is running

• Advanced Vision Care — Los Angeles, California, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• The Eye Institute of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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