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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02315456
• Collaborator: OptiMedica Corporation (Industry)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.3
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Dec 1, 2014
• Actual Primary Completion Date: Aug 9, 2016
• Actual Study Completion Date: Aug 9, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 95 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• OptiMedica Corporation

Investigators

• Principal Investigator: Surendra Basti, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Surendra Basti, Associate Professor of Ophthalmology, Northwestern University
• ClinicalTrials.gov Identifier: NCT02315456
• Other Study ID Numbers: 1234
• First Posted: Dec 11, 2014
• Last Update Posted: Feb 10, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Surendra Basti, Associate Professor of Ophthalmology, Northwestern University: capsulorhexis; IOL centration

Study Results

No Results Posted as of Feb 10, 2020