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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02315456
Enrollment
50
Registered
2014-12-11
Start date
2014-12-31
Completion date
2016-08-09
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Capsulorhexis

Keywords

capsulorhexis, IOL centration

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.

Interventions

PROCEDUREcapsulorhexis

Sponsors

OptiMedica Corporation
CollaboratorINDUSTRY
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 95 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Overlap of the Continuous Curvilinear Capsulorhexis margin over the IOL10-30 days post surgeryThe 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026