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
  Purpose

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 Intervention
Cataract
Refractive Surgery
Astigmatism
Procedure: Nasal 2.8-mm corneal incision
Procedure: Temporal 2.8-mm corneal incision
Procedure: Superior 2.8-mm incision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Induced corneal refractive change [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ISV change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Phacoemulsification superior incision

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742950

Locations
Spain
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaime Tejedor / Dr, Hospital Ramón y Cajal
ClinicalTrials.gov Identifier: NCT00742950     History of Changes
Other Study ID Numbers: CINPHACO
Study First Received: August 26, 2008
Last Updated: June 24, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitario Ramon y Cajal:
Corneal incision
Cataract surgery
Phacoemulsification
Surgically induced astigmatism
Corneal Topography

Additional relevant MeSH terms:
Astigmatism
Cataract
Refractive Errors
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on July 22, 2014