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

February 6, 2020 updated by: Surendra Basti, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

50

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

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

45 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Capsule centration
Capsulorhexis made with capsule centration
Procedure: capsulorhexis
Other: Pupil centration
Capsulorhexis made with pupil centration
Procedure: capsulorhexis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10-30 days post surgery

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

OptiMedica Corporation

Investigators

  • Principal Investigator: Surendra Basti, MD, Northwestern University

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 (Actual)

December 1, 2014

Primary Completion (Actual)

August 9, 2016

Study Completion (Actual)

August 9, 2016

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1234 (Department of Defense)

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.

Clinical Trials on capsulorhexis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe