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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02315456
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : February 10, 2020
OptiMedica Corporation
Information provided by (Responsible Party):
Surendra Basti, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Capsulorhexis Procedure: capsulorhexis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Evaluation of Centration of Intraocular Lens With Two Laser Settings for Capsulorhexis With Femtosecond Laser
Actual Study Start Date : December 2014
Actual Primary Completion Date : August 9, 2016
Actual Study Completion Date : August 9, 2016

Arm Intervention/treatment
Capsule centration
Capsulorhexis made with capsule centration
Procedure: capsulorhexis
Pupil centration
Capsulorhexis made with pupil centration
Procedure: capsulorhexis

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02315456

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
OptiMedica Corporation
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Principal Investigator: Surendra Basti, MD Northwestern University

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Responsible Party: Surendra Basti, Associate Professor of Ophthalmology, Northwestern University Identifier: NCT02315456    
Other Study ID Numbers: 1234
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Keywords provided by Surendra Basti, Northwestern University:
IOL centration