A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

• Sponsor: Edward E. Manche (Other)
• Overall Status: Completed
• CT.gov ID: NCT03063164
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Comparing LASIK outcomes using two femtosecond lasers

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism	Device: Intralase IFS150; Device: Visumax	N/A

Detailed Description

Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Eye to eye comparisonEye to eye comparison
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax
• Actual Study Start Date: Feb 14, 2017
• Actual Primary Completion Date: Nov 13, 2018
• Actual Study Completion Date: Nov 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intralase IFS Intralase IFS vs. Visumax	Device: Intralase IFS150; Intralase flap creation
Active Comparator: Visumax Visumax vs. Intralase iFS	Device: Visumax; Visumax flap creation

Outcome Measures

Primary Outcome Measures

1. ETDRS Uncorrected Visual Acuity [At post-operative month 12]

   Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

Secondary Outcome Measures

1. Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness [At postoperative month one]

   Anterior segment ocular coherence tomography

2. Cochet Bonnet Asthesiometry Measurement of Corneal Sensation [At postoperative month twelve]

   Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.

3. Best Spectacle Corrected Visual Acuity [Postoperative month 12]

   Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts

4. Aberrometry [One three, six and twelve months]

   Aberrometry images will be obtained on the iDesign aberrometer

5. Questionnaire Measuring Patient Preference for Laser Device [Intraoperative (Approximately 1 minute after completion of surgery)]

   Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.

6. Patient Reported Outcomes With LASIK [One month, three months, six months and twelve months]

   PROWL study questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.

Exclusion Criteria:

• Subjects under the age of 21

• Subjects over the age of 60

• Subjects with corneal ectatic disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Byers Eye Institute at Stanford	Palo Alto	California	United States	94303

Sponsors and Collaborators

• Edward E. Manche

Investigators

• Principal Investigator: Edward Manche, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol - Mar 6, 2018

More Information

Publications

None provided.

• Responsible Party: Edward E. Manche, Professor of Ophthalmology, Stanford University
• ClinicalTrials.gov Identifier: NCT03063164
• Other Study ID Numbers: 33356
• First Posted: Feb 24, 2017
• Last Update Posted: Dec 14, 2021
• Last Verified: Nov 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 Edward E. Manche, Professor of Ophthalmology, Stanford University: Femtosecond laser; Visumax; Intralase IFS150; LASIK
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Intralase IFS Eye	Visumax Eye
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Period Title: Overall Study
STARTED	7	7
COMPLETED	7	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Overall Participants	7
Overall Eyes	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	6 85.7%
Male	1 14.3%
Race/Ethnicity, Customized (Count of Participants)
Asian	5 71.4%
Caucasian	2 28.6%
Region of Enrollment (Count of Participants)
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	ETDRS Uncorrected Visual Acuity
Description	Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
Time Frame	At post-operative month 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intralase IFS Eye	Visumax Eye
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Measure Participants	7	7
Measure Eyes	7	7
Count of Units [Eyes]	5	5

2. Secondary Outcome

Title	Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness
Description	Anterior segment ocular coherence tomography
Time Frame	At postoperative month one

Outcome Measure Data

Analysis Population Description

Data were corrupted and could not be analyzed

Arm/Group Title	Intralase IFS Eye	Visumax Eye
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Measure Participants	0	0

3. Secondary Outcome

Title	Cochet Bonnet Asthesiometry Measurement of Corneal Sensation
Description	Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.
Time Frame	At postoperative month twelve

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intralase IFS Eye	Visumax Eye
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Measure Participants	7	7
Measure Eyes	7	7
Score of greater than or equal to 5	7	7
Score of less than 5	0	0

4. Secondary Outcome

Title	Best Spectacle Corrected Visual Acuity
Description	Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
Time Frame	Postoperative month 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intralase IFS Eye	Visumax Eye
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Measure Participants	7	7
Measure Eyes	7	7
Count of Units [Eyes]	0	0

5. Secondary Outcome

Title	Aberrometry
Description	Aberrometry images will be obtained on the iDesign aberrometer
Time Frame	One three, six and twelve months

Outcome Measure Data

Analysis Population Description

The data were corrupted and could not be analyzed

Arm/Group Title	Intralase IFS Eye	Visumax Eye
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Measure Participants	0	0

6. Secondary Outcome

Title	Questionnaire Measuring Patient Preference for Laser Device
Description	Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.
Time Frame	Intraoperative (Approximately 1 minute after completion of surgery)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Measure Participants	7
Preferred Visumax	3 42.9%
Preferred Intralase IFS	2 28.6%
No preference	2 28.6%

7. Secondary Outcome

Title	Patient Reported Outcomes With LASIK
Description	PROWL study questionnaire
Time Frame	One month, three months, six months and twelve months

Outcome Measure Data

Analysis Population Description

Questionnaire data were corrupted and could not be analyzed.

Arm/Group Title	Intralase IFS Eye	Visumax Eye
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Measure Participants	0	0

Adverse Events

Time Frame	Twelve months
Adverse Event Reporting Description	Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treated eye.
Arm/Group Title	Intralase IFS Eye		Visumax Eye
Arm/Group Description	Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.		Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
All Cause Mortality
	Intralase IFS Eye		Visumax Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Intralase IFS Eye		Visumax Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Intralase IFS Eye		Visumax Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)

Limitations/Caveats

The study did not meet its planned enrollment number

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.