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

NCT ID: NCT04477421

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FS-LASIK Group

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

Group Type ACTIVE_COMPARATOR

S-LASIK

Intervention Type PROCEDURE

Femtosecond laser Insitu keratomileusis

FS-SMILE

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

Group Type EXPERIMENTAL

FS-SMILE

Intervention Type PROCEDURE

Femtosecond small incision lenticule extraction

Interventions

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FS-SMILE

Femtosecond small incision lenticule extraction

Intervention Type PROCEDURE

S-LASIK

Femtosecond laser Insitu keratomileusis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Rasheed University College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Al-Rasheed University College

Baghdad, AL-Adhmia, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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AR200106

Identifier Type: -

Identifier Source: org_study_id

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