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Refractive Change Induced by 2.8-mm Corneal Incision (CINPHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00742950
Recruitment Status : Completed
First Posted : August 28, 2008
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Hospital Universitario Ramon y Cajal

Tracking Information
First Submitted Date  ICMJE August 26, 2008
First Posted Date  ICMJE August 28, 2008
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE August 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2008)
Induced corneal refractive change [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2008)
  • ISV change [ Time Frame: 6 months ]
  • Visual acuity [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Refractive Change Induced by 2.8-mm Corneal Incision
Official Title  ICMJE Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Refractive Surgery
  • Astigmatism
Intervention  ICMJE
  • Procedure: Nasal 2.8-mm corneal incision
    Phacoemulsification through a nasal 2.8-mm incision
    Other Name: Phacoemulsification nasal incision
  • Procedure: Temporal 2.8-mm corneal incision
    Phacoemulsification through a 2.8-mm temporal incision
    Other Name: Phacoemulsification temporal incision
  • Procedure: Superior 2.8-mm incision
    Phacoemulsification through a superior 2.8-mm corneal incision
    Other Name: Phacoemulsification superior incision
Study Arms  ICMJE
  • Active Comparator: I
    Nasal 2.8-mm corneal incision
    Intervention: Procedure: Nasal 2.8-mm corneal incision
  • Active Comparator: II
    Temporal 2.8-mm corneal incision
    Intervention: Procedure: Temporal 2.8-mm corneal incision
  • Active Comparator: III
    Superior 2.8-mm corneal incision
    Intervention: Procedure: Superior 2.8-mm incision
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 27, 2008)
108
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Visual impairment for daily tasks caused by cataract
  • Age older than 50 years
  • Steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20°
  • Ability to cooperate in the protocol procedures

Exclusion Criteria:

  • Age below 50
  • Inability to cooperate with measurements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00742950
Other Study ID Numbers  ICMJE CINPHACO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaime Tejedor / Dr, Hospital Ramón y Cajal
Study Sponsor  ICMJE Hospital Universitario Ramon y Cajal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jaime Tejedor, MD, PhD Dept Ophthalmology
Study Chair: José A Pérez-Rodríguez, MD Dept Ophthalmology
PRS Account Hospital Universitario Ramon y Cajal
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP