Back to resultsRefractive Change Induced by 2.8-mm Corneal Incision (CINPHA)
Primary Purpose
Cataract, Refractive Surgery, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nasal 2.8-mm corneal incision
Temporal 2.8-mm corneal incision
Superior 2.8-mm incision
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Corneal incision, Cataract surgery, Phacoemulsification, Surgically induced astigmatism, Corneal Topography
Eligibility Criteria
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
Sites / Locations
- Dept Ophthalmology, Hospital Universitario Ramón y Cajal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
I
II
III
Arm Description
Nasal 2.8-mm corneal incision
Temporal 2.8-mm corneal incision
Superior 2.8-mm corneal incision
Outcomes
Primary Outcome Measures
Induced corneal refractive change
Secondary Outcome Measures
ISV change
Visual acuity
Full Information
NCT ID
NCT00742950
First Posted
August 26, 2008
Last Updated
June 24, 2011
Sponsor
Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT00742950
Brief Title
Refractive Change Induced by 2.8-mm Corneal Incision
Acronym
CINPHA
Official Title
Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario Ramon y Cajal
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Refractive Surgery, Astigmatism
Keywords
Corneal incision, Cataract surgery, Phacoemulsification, Surgically induced astigmatism, Corneal Topography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Description
Nasal 2.8-mm corneal incision
Arm Title
II
Arm Type
Active Comparator
Arm Description
Temporal 2.8-mm corneal incision
Arm Title
III
Arm Type
Active Comparator
Arm Description
Superior 2.8-mm corneal incision
Intervention Type
Procedure
Intervention Name(s)
Nasal 2.8-mm corneal incision
Other Intervention Name(s)
Phacoemulsification nasal incision
Intervention Description
Phacoemulsification through a nasal 2.8-mm incision
Intervention Type
Procedure
Intervention Name(s)
Temporal 2.8-mm corneal incision
Other Intervention Name(s)
Phacoemulsification temporal incision
Intervention Description
Phacoemulsification through a 2.8-mm temporal incision
Intervention Type
Procedure
Intervention Name(s)
Superior 2.8-mm incision
Other Intervention Name(s)
Phacoemulsification superior incision
Intervention Description
Phacoemulsification through a superior 2.8-mm corneal incision
Primary Outcome Measure Information:
Title
Induced corneal refractive change
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ISV change
Time Frame
6 months
Title
Visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Tejedor, MD, PhD
Organizational Affiliation
Dept Ophthalmology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José A Pérez-Rodríguez, MD
Organizational Affiliation
Dept Ophthalmology
Official's Role
Study Chair
Facility Information:
Facility Name
Dept Ophthalmology, Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
15860279
Citation
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.
Results Reference
background
PubMed Identifier
19011013
Citation
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.
Results Reference
derived
Learn more about this trial
Refractive Change Induced by 2.8-mm Corneal Incision
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