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Completed

NCT Number: NCT04477421

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

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Rasheed University College

Baghdad, AL-Adhmia, 12221, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FS-SMILE

Procedure

Femtosecond small incision lenticule extraction

S-LASIK

Procedure

Femtosecond laser Insitu keratomileusis

Primary outcomes

  1. Ocular Surface Disease Index

    Time frame: After 1 month of surgery

    Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease

  2. Ocular Surface Disease Index

    Time frame: After 6 months of surgery

    Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease

  3. Tear Break-Up Time

    Time frame: After 1 month of surgery

    Tear Break-Up Time (in seconds)

  4. Tear Break-Up Time

    Time frame: After 6 months of surgery

    Tear Break-Up Time (in seconds)

  5. Schirmer I test

    Time frame: After 1 month of surgery

    Schirmer I test (in mm/5 minutes)

  6. Schirmer I test

    Time frame: After 6 months of surgery

    Schirmer I test (in mm/5 minutes)

  7. Oxford score

    Time frame: After 1 month of surgery

    Oxford score (the score range from 0 to 5), higher value indicate more severe disease

  8. Oxford score

    Time frame: After 6 months of surgery

    Oxford score (the score range from 0 to 5), higher value indicate more severe disease

  9. Dry Eye Work Shop scale

    Time frame: After 1 month of surgery

    Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease

  10. Dry Eye Work Shop scale

    Time frame: After 6 months of surgery

    Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease

Sponsors and collaborators

Lead sponsor

Al-Rasheed University College

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2020
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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