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

June 24, 2011 updated by: Hospital Universitario Ramon y Cajal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Dept Ophthalmology, Hospital Universitario Ramón y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Induced corneal refractive change
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 6 months
6 months
ISV change
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Ramon y Cajal

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 24, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINPHACO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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