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CompletedNCT02315456Updated Feb 10, 2020

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

An interventional study of capsulorhexis in Capsulorhexis, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 45 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-10.

Sponsored by Northwestern University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
45 Years to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Capsulorhexis

Keywords

  • capsulorhexis
  • IOL centration
03

In context

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    Capsule centration

    Capsulorhexis made with capsule centration

    Procedure: capsulorhexis

  • Other
    Pupil centration

    Capsulorhexis made with pupil centration

    Procedure: capsulorhexis

Interventions

  • Procedurecapsulorhexis
06

What researchers measure

Primary outcomes

  1. Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL

    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

    Time frame: 10-30 days post surgery

07

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
08

References and documents

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. doi: 10.1016/j.jcrs.2006.10.054. PubMed 17321392 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02315456
Lead sponsor
Northwestern University
Collaborators
OptiMedica Corporation
Responsible party
Surendra Basti (Associate Professor of Ophthalmology, Northwestern University) — Principal investigator
First posted
Dec 11, 2014
Start date
Dec 2014
Primary completion
Aug 9, 2016
Completion
Aug 9, 2016
Last update
Feb 10, 2020

Study contacts

Surendra Basti, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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