Refractive Change Induced by 2.8-mm Corneal Incision

Cataract Clinical Trial

— CINPHA  

Official title:

Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742950
• Other study ID #: CINPHACO
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: June 24, 2011
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2010
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Refractive Surgery

Intervention

Procedure:
• Nasal 2.8-mm corneal incision
Phacoemulsification through a nasal 2.8-mm incision
• Temporal 2.8-mm corneal incision
Phacoemulsification through a 2.8-mm temporal incision
• Superior 2.8-mm incision
Phacoemulsification through a superior 2.8-mm corneal incision

Locations

Country	Name	City	State
Spain	Dept Ophthalmology, Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induced corneal refractive change		6 months	No
Secondary	ISV change		6 months	No
Secondary	Visual acuity		6 months	No