NCT00742950|CompletedDMC
Refractive Change Induced by 2.8-mm Corneal Incision
CINPHA
Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
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CINPHA
Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
Sponsor study identifier
interventional
108
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
December 2009
Actual (reported)The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral. Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification. Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 26, 2008
Actual (reported)August 28, 2008
Actual (reported)September 2009
Actual (reported)December 2009
Actual (reported)Induced corneal refractive change
6 months
ISV change
6 months
Visual acuity
6 months
Nasal 2.8-mm corneal incision
Temporal 2.8-mm corneal incision
Superior 2.8-mm corneal incision
Phacoemulsification through a nasal 2.8-mm incision
Phacoemulsification through a 2.8-mm temporal incision
Dept Ophthalmology, Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034, Spain
Tejedor J, Murube J. Choosing the location of corneal incision based on preexisting astigmatism in phacoemulsification. Am J Ophthalmol. 2005 May;139(5):767-76. doi: 10.1016/j.ajo.2004.12.057.
Tejedor J, Perez-Rodriguez JA. Astigmatic change induced by 2.8-mm corneal incisions for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):989-94. doi: 10.1167/iovs.08-2778. Epub 2008 Nov 14.
Jaime Tejedor, MD, PhD
Dept Ophthalmology
José A Pérez-Rodríguez, MD
Dept Ophthalmology
First Submitted
August 26, 2008
First Posted
August 28, 2008
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Phacoemulsification through a superior 2.8-mm corneal incision
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Study Completion
December 2009
Actual (reported)Last Updated
June 27, 2011
Record last verified: 2010-05
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Source: ClinicalTrials.gov.
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