Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes

• Sponsor: Gainesville Eye Associates (Other)
• Overall Status: Completed
• CT.gov ID: NCT04126174
• Collaborator: Science in Vision (Other)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: femtosecond laser system arcuate corneal incision; Other: Manual LRI	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Contralateral eye studyContralateral eye study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
• Actual Study Start Date: Oct 15, 2019
• Actual Primary Completion Date: Mar 20, 2021
• Actual Study Completion Date: Mar 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Femtosecond limbal relaxing incision (LRI) Eyes will be treated with arcuate incisions from a femtosecond laser system.	Device: femtosecond laser system arcuate corneal incision; Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.; Other Names: LRI
Active Comparator: Manual LRI Eyes will be treated with arcuate incisions completed manually with a blade.	Other: Manual LRI; Manual LRI

Outcome Measures

Primary Outcome Measures

1. Residual Refractive Astigmatism [3 months]

   Residual refractive astigmatism measured in diopters

Secondary Outcome Measures

1. Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D) [3 months]

   The number of eyes with residual refractive astigmatism < 0.50 diopters (D)

2. Uncorrected Monocular Distance Visual Acuity [3 months]

   Uncorrected monocular distance visual acuity in logMAR

3. Spherical Equivalent Refraction [3 months]

   Spherical equivalent refraction in diopters

4. Corneal Astigmatism [3 months]

   Anterior corneal astigmatism

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• are willing and able to understand and sign an informed consent;

• are willing and able to attend all study visits;

• are more than 40 years of age, of either gender and any race;

• are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens

• have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)

• have 0.50 D to 1.75 D of regular corneal astigmatism

• have potential acuity of 20/25 or better

• Are scheduled to have a non-toric monofocal intraocular lens (IOL) (SN60WF) lens implanted in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Irregular astigmatism (e.g. keratoconus)

• Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)

• Monocular status (e.g. amblyopia)

• Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)

• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)

• Diabetic retinopathy

• Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)

• History of retinal detachment

• Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gainesville Eye Associates	Gainesville	Georgia	United States	30501

Sponsors and Collaborators

• Gainesville Eye Associates
• Science in Vision

Investigators

• Principal Investigator: Clayton G Blehm, MD, Gainesville Eye Associates

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 7, 2019

More Information

Publications

None provided.

• Responsible Party: Gainesville Eye Associates
• ClinicalTrials.gov Identifier: NCT04126174
• Other Study ID Numbers: CB-19-001
• First Posted: Oct 15, 2019
• Last Update Posted: Sep 5, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Gainesville Eye Associates: astigmatism, limbal relaxing incisions
• Additional relevant MeSH terms: Cataract; Surgical Wound

Study Results

Participant Flow

Arm/Group Title	Femtosecond Limbal Relaxing Incision (LRI)	Manual LRI
Arm/Group Description	Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Period Title: Overall Study
STARTED	41	41
COMPLETED	38	38
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
Overall Participants	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69 (7)
Sex: Female, Male (Count of Participants)
Female	21 55.3%
Male	17 44.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	38 100%

Outcome Measures

1. Primary Outcome

Title	Residual Refractive Astigmatism
Description	Residual refractive astigmatism measured in diopters
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Femtosecond Limbal Relaxing Incision (LRI)	Manual LRI
Arm/Group Description	Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Measure Participants	38	38
Measure Eyes	38	38
Mean (Standard Deviation) [diopters]	.21 (.33)	.22 (.31)

2. Secondary Outcome

Title	Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)
Description	The number of eyes with residual refractive astigmatism < 0.50 diopters (D)
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Femtosecond Limbal Relaxing Incision (LRI)	Manual LRI
Arm/Group Description	Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Measure Participants	38	38
Measure Eyes	38	38
Count of Units [Eyes]	36	34

3. Secondary Outcome

Title	Uncorrected Monocular Distance Visual Acuity
Description	Uncorrected monocular distance visual acuity in logMAR
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Femtosecond Limbal Relaxing Incision (LRI)	Manual LRI
Arm/Group Description	Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Measure Participants	38	38
Measure Eyes	38	38
Mean (Standard Deviation) [logMAR]	.1 (.12)	.08 (.10)

4. Secondary Outcome

Title	Spherical Equivalent Refraction
Description	Spherical equivalent refraction in diopters
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Femtosecond Limbal Relaxing Incision (LRI)	Manual LRI
Arm/Group Description	Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Measure Participants	38	38
Measure Eyes	38	38
Mean (Standard Deviation) [diopters]	-.02 (.37)	0 (.27)

5. Secondary Outcome

Title	Corneal Astigmatism
Description	Anterior corneal astigmatism
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Femtosecond Limbal Relaxing Incision (LRI)	Manual LRI
Arm/Group Description	Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.	Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
Measure Participants	38	38
Measure Eyes	38	38
Mean (Standard Deviation) [diopters]	.63 (.34)	.7 (.4)

Adverse Events

Time Frame	3 months
Arm/Group Title	Femtosecond Limbal Relaxing Incision (LRI)		Manual LRI
Arm/Group Description	Eyes will be treated with arcuate incisions from a femtosecond laser system. femtosecond laser system arcuate corneal incision: Corneal arcuate incision made with a femtosecond laser system.		Eyes will be treated with arcuate incisions completed manually with a blade. Manual LRI: Manual LRI
All Cause Mortality
	Femtosecond Limbal Relaxing Incision (LRI)		Manual LRI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)
Serious Adverse Events
	Femtosecond Limbal Relaxing Incision (LRI)		Manual LRI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Femtosecond Limbal Relaxing Incision (LRI)		Manual LRI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		2/41 (4.9%)
Eye disorders
Full thickness perforation	0/41 (0%)	0	2/41 (4.9%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.