NCT02315456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2016

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

December 9, 2014

Last Update Submit

February 6, 2020

Conditions

Capsulorhexis

Keywords

capsulorhexisIOL centration

Outcome Measures

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

    10-30 days post surgery

Study Arms (2)

Capsule centration

OTHER

Capsulorhexis made with capsule centration

Procedure: capsulorhexis

Pupil centration

OTHER

Capsulorhexis made with pupil centration

Procedure: capsulorhexis

Interventions

capsulorhexisPROCEDURE
Capsule centrationPupil centration

Eligibility Criteria

Age45 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

    PMID: 17321392BACKGROUND

MeSH Terms

Interventions

Capsulorhexis

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Surendra Basti, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 11, 2014

Study Start

December 1, 2014

Primary Completion

August 9, 2016

Study Completion

August 9, 2016

Last Updated

February 10, 2020

Record last verified: 2020-02

Locations

US(1)