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

Not Applicable

Completed

• Conditions: Capsulorhexis
• Interventions: Procedure: capsulorhexis

• Registration Number: NCT02315456
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Primary Completion: 2016-08-09
• Study Completion: 2016-08-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsule centration	capsulorhexis	Capsulorhexis made with capsule centration
Pupil centration	capsulorhexis	Capsulorhexis made with pupil centration

Primary Outcome Measures

Name	Time	Method
Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL	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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States