Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease

Al-Rasheed University College

Status: Completed

Conditions: Dry Eye Disease

Treatments: Procedure: S-LASIK; Procedure: FS-SMILE

Study type: Interventional

Funder types: Other

Identifiers

NCT04477421

AR200106

Details and patient eligibility

About

Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters

Exclusion criteria

• sign or symptom of dry eye disease (tear film breakup time (TBUT) >10 seconds
• Schirmer I test >10 mm /5 minutes)
• corneal or conjunctival staining
• Meibomian gland dysfunction
• Previous ocular and or eyelid medical or surgical treatment
• pregnancy
• Chronic systemic disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

FS-LASIK Group

Active Comparator group

Description:

100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis)

Treatment:

Procedure: S-LASIK

FS-SMILE

Experimental group

Description:

100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction)

Treatment:

Procedure: FS-SMILE