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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00742950
First received: August 26, 2008
Last updated: June 24, 2011
Last verified: May 2010
History of Changes

August 26, 2008
June 24, 2011
August 2008
September 2009   (final data collection date for primary outcome measure)
Induced corneal refractive change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00742950 on ClinicalTrials.gov Archive Site
  • ISV change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Refractive Change Induced by 2.8-mm Corneal Incision
Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cataract
  • Refractive Surgery
  • Astigmatism
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00742950
CINPHACO
Yes
Jaime Tejedor / Dr, Hospital Ramón y Cajal
Hospital Universitario Ramon y Cajal
Not Provided
Principal Investigator: Jaime Tejedor, MD, PhD Dept Ophthalmology
Study Chair: José A Pérez-Rodríguez, MD Dept Ophthalmology
Hospital Universitario Ramon y Cajal
May 2010

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