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CINPHA: Refractive Change Induced by 2.8-mm Corneal Incision

Sponsor
Hospital Universitario Ramon y Cajal (Other)
Overall Status
Completed
CT.gov ID
NCT00742950
Collaborator
(none)
108
Enrollment
1
Location
3
Arms
16
Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Nasal 2.8-mm corneal incision
  • Procedure: Temporal 2.8-mm corneal incision
  • Procedure: Superior 2.8-mm incision
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: I

Nasal 2.8-mm corneal incision

Procedure: Nasal 2.8-mm corneal incision
Phacoemulsification through a nasal 2.8-mm incision
Other Names:
  • Phacoemulsification nasal incision

    		•
    Active Comparator: II

    Temporal 2.8-mm corneal incision

    Procedure: Temporal 2.8-mm corneal incision
    Phacoemulsification through a 2.8-mm temporal incision
    Other Names:
  • Phacoemulsification temporal incision

    		•
    Active Comparator: III

    Superior 2.8-mm corneal incision

    Procedure: Superior 2.8-mm incision
    Phacoemulsification through a superior 2.8-mm corneal incision
    Other Names:
  • Phacoemulsification superior incision

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Induced corneal refractive change [6 months]

    Secondary Outcome Measures

    1. ISV change [6 months]

    2. Visual acuity [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept Ophthalmology, Hospital Universitario Ramón y Cajal Madrid Spain 28034

    Sponsors and Collaborators

    • Hospital Universitario Ramon y Cajal

    Investigators

    • Principal Investigator: Jaime Tejedor, MD, PhD, Dept Ophthalmology
    • Study Chair: José A Pérez-Rodríguez, MD, Dept Ophthalmology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00742950
    Other Study ID Numbers:
    • CINPHACO
    First Posted:
    Aug 28, 2008
    Last Update Posted:
    Jun 27, 2011
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    Corneal incision
    Cataract surgery
    Phacoemulsification
    Surgically induced astigmatism
    Corneal Topography
    Additional relevant MeSH terms:
    Cataract
    Astigmatism

    Study Results

    No Results Posted as of Jun 27, 2011