Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: femtosecond laser system arcuate corneal incision; Other: Manual LRI

• Registration Number: NCT04126174
• Lead Sponsor: Gainesville Eye Associates

Brief Summary

This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.

Detailed Description

This study is a comparative, prospective, randomized contralateral eye study of visual outcomes after LenSx laser arcuate relaxing incisions utilizing the Woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the Donnenfeld nomogram. Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the Lenstar and slit lamp exam.

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-14
• Study Start: 2019-10-15
• Study First Posted: 2019-10-15
• Status Verified: 2021-02
• Primary Completion: 2021-03-20
• Study Completion: 2021-03-20
• Results First Submitted: 2021-07-19
• Results First Submitted QC: 2021-09-03
• Last Update Submitted: 2021-09-03
• Results First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femtosecond limbal relaxing incision (LRI)	femtosecond laser system arcuate corneal incision	Eyes will be treated with arcuate incisions from a femtosecond laser system.
Manual LRI	Manual LRI	Eyes will be treated with arcuate incisions completed manually with a blade.

Primary Outcome Measures

Name	Time	Method
Residual Refractive Astigmatism	3 months	Residual refractive astigmatism measured in diopters

Secondary Outcome Measures

Name	Time	Method
Corneal Astigmatism	3 months	Anterior corneal astigmatism
Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)	3 months	The number of eyes with residual refractive astigmatism \< 0.50 diopters (D)
Uncorrected Monocular Distance Visual Acuity	3 months	Uncorrected monocular distance visual acuity in logMAR
Spherical Equivalent Refraction	3 months	Spherical equivalent refraction in diopters

Trial Locations

Locations (1)

Gainesville Eye Associates; 🇺🇸 Gainesville, Georgia, United States