A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

E

Edward E. Manche

Status

Completed

Conditions

Myopia
Astigmatism

Treatments

Device: Intralase IFS150
Device: Visumax

Study type

Interventional

Funder types

Other

Identifiers

NCT03063164
33356

Details and patient eligibility

About

Comparing LASIK outcomes using two femtosecond lasers

Full 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.

Enrollment

7 patients

Sex

All

Ages

21 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

7 participants in 2 patient groups

Intralase IFS
Active Comparator group
Description:
Intralase IFS vs. Visumax
Treatment:
Device: Intralase IFS150
Visumax
Active Comparator group
Description:
Visumax vs. Intralase iFS
Treatment:
Device: Visumax

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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