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Comparison of efficacy and safety between two surgical techniques for correcting eyeglasses errors: small-incision lenticule extraction (SMILE) and femtolaser-assisted in situ keratomileusis (femtoLASIK)

Comparison of efficacy and safety between small-incision lenticule extraction (SMILE) and femtolaser-assisted in situ keratomileusis (femtoLASIK) optimized by wavefront analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9k4bdds
Enrollment
Unknown
Registered
2022-08-12
Start date
2016-05-25
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Myopia

Interventions

50 patients will be selected, who will integrate an interventional, comparative, randomized, prospective study, involving 100 eyes. There will be no blinding in the study, as the patient, surgeon and
there is no gender preference
age 18 years or older
myopia or compound myopic astigmatism (with spherical equivalent between -1.00D and -8.00D and astigmatism up to 4.00D). Exclusion Criteria: Diagnosis of any systemic disease, such as diabetes, hypert

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Spontaneous participation of the patient in the study; there is no gender preference; age 18 years or older; myopia or compound myopic astigmatism (with spherical equivalent between -1.00D and -8,00D and astigmatism up to 4.00D)

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Diagnosis of any systemic disease such as diabetes, hypertension, rheumatologic conditions and neurological conditions; eye conditions such as dry eye, corneal opacities, central corneal thickness below 480 microns, manifest or suspected corneal ectasia

Design outcomes

Primary

MeasureTime frame
Assess postoperative visual acuity between the eyes. It is expected to find similar visual acuity between eyes operated on with the different techniques. For visual acuity assessment, a standard visual acuity table (Snellen's optotypes) will be used at a distance of 4 meters

Secondary

MeasureTime frame
Contrast sensitivity assessment (FACT, Stereo Optical Co., Chicago, Illinois, USA) will be determined in each eye using the best corrected visual acuity at spatial frequencies of 1.5, 3, 6, 12, and 18 CPD under photopic conditions. . The log base 10 contrast sensitivity values ??will be used to build a graph for each spatial frequency tested. It is expected to find similar values ??of contrast sensitivity at the frequencies tested between the eyes operated on with the different techniques;A satisfaction questionnaire will be applied and patients will be asked to assess their vision as bad, reasonable, good or excellent. They will be additionally asked to rate ocular pain, far vision difficulty, near vision difficulty, glare, photophobia, vision fluctuation, image distortion and foreign-body sensation in each eye. Each feature will be graded on a 0-3 scale, with 0 indicating absence of symptoms and 3 indicating the worst symptoms. It is expected to find a similar result of satisfaction between the 2 techniques

Countries

Brazil

Contacts

Public ContactFelipe Jorge

Universidade Federal de São Paulo

felipeabdojorge@gmail.com+55(11)949724652

Outcome results

None listed

Source: REBEC (via WHO ICTRP)