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Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser

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ClinicalTrials.gov Identifier: NCT02315456
Recruitment Status : Unknown
Verified December 2014 by Surendra Basti, Northwestern University.
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Collaborator:
OptiMedica Corporation
Information provided by (Responsible Party):
Surendra Basti, Northwestern University

Tracking Information
First Submitted Date  ICMJE December 9, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date December 11, 2014
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL [ Time Frame: 10-30 days post surgery ]
The horizontal and vertical overlap will be calculated. Horizontal overlap= Overlap of the temporal half versus the nasal half Vertical overlap= overlap of the superior half versus the inferior half of the IOL. Symmetricity of overlap= Horizontal overlap/vertical overlap
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Centration of Intraocular Lens With Two Settings for Capsulorhexis With Femtosecond Laser
Official Title  ICMJE Prospective Randomized Evaluation of Centration of Intraocular Lens With Two Laser Settings for Capsulorhexis With Femtosecond Laser
Brief Summary The study compares anatomic outcomes of Intra Ocular Lens(IOL) placement with two methods of centration of the capsulorhexis- scanned capsule centration and pupil centration. It is hypothesized that scanned capsule centration provides more uniform(25% better) overlap of capsulorhexis margin over IOL optic compared to pupil centration.
Detailed Description

50 consecutive eyes undergoing cataract surgery will be studied. 25 eyes will have scanned capsule centration and 25 will have pupil centration. Retroillumination slitlamp photographs will be taken 10-30 days after surgery with dilated pupils. The amount of capsule overlapping the IOL will be documented. The horizontal, vertical and symmetricity of overlap will be calculated.

Each group will have 20 eyes with an additional 5 eyes in each group to account for drop outs or poor quality images.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Capsulorhexis
Intervention  ICMJE Procedure: capsulorhexis
Study Arms  ICMJE
  • Capsule centration
    Capsulorhexis made with capsule centration
    Intervention: Procedure: capsulorhexis
  • Pupil centration
    Capsulorhexis made with pupil centration
    Intervention: Procedure: capsulorhexis
Publications * de Castro A, Rosales P, Marcos S. Tilt and decentration of intraocular lenses in vivo from Purkinje and Scheimpflug imaging. Validation study. J Cataract Refract Surg. 2007 Mar;33(3):418-29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 10, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with cataracts
  • Same variety of IOL inserted in all eyes

Exclusion Criteria:

  • Previous glaucoma or retinal surgery
  • Pupil not dilating beyond 6mm
  • Zonular weakness or pseudoexfoliation
  • Extensive corneal scarring
  • High refractive error: Myopia greater than 10D, Hyperopia greater than 5D
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02315456
Other Study ID Numbers  ICMJE 1234
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Surendra Basti, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE OptiMedica Corporation
Investigators  ICMJE
Principal Investigator: Surendra Basti, MD Northwestern University
PRS Account Northwestern University
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP