Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye

NCT04831177 | Completed

• 1 other identifier: TFLADE
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Laser in situ keratomileusis (LASIK) eye surgery continues to be the most common refractive procedure used to correct different forms of ametropia. Although the introduction of femtosecond technology has markedly reduced the incidence of intraoperative flap complications and allowed a better control on flap parameters, dry eye remains one of the most challenging postoperative complications.

Conditions

Myopic LASIK Candidates With Spherical Equivalent up to - 10 Diopters

Keywords

Dry eye; Femtolaser; Laser in situ keratomileusis

Outcome Measures

Primary Outcomes (5)

• Tear film break up time TBUT

  Fluorescein strip was inserted in the lower conjunctival fornix for few seconds then removed and the patient was asked to frequently blink, the stained tear film was observed with slit lamp (cobalt blue filter) till the appearance of the first black (dry) spot and the time interval in seconds was measured

  6 months

• Schirmer I test

  Whatman filter paper (35 mm long) was folded 5mm and inserted in the lower conjunctival fornix away from the cornea and the patient was asked to blink normally. After 5minutes the paper was removed, and the amount of wetting in millimeters was measured.

  6 months

• Ocular Surface Disease Index OSDI

  A questionnaire consisting of 12 questions. Each question with a score from 0 to 4, the OSDI score is calculated by multiplying the sum by 25 and dividing by the number of questions answered. This yields a score from 0 to 100. The results of OSDI score can be graded as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eye (33-100)

  6 months

• Lower Tear meniscus height (LTMH)

  Anterior segment Optical coherence tomography (AS-OCT) examination was scheduled in the afternoon. The lower TMH was evaluated with a vertical scan centered on the inferior cornea and the lower eyelid. The lower TMH was measured with a special caliper tool incorporated in the device in micrometers and the height of the tear meniscus is the distance between 2 points ,one where the meniscus intersects the inferior cornea superiorly and the other where the meniscus intersects the lower eyelid margin inferiorly.

  6 months

• Lower Tear meniscus area (LTMA)

  The lower TMA was evaluated using AS-OCT with a vertical scan centered on the inferior cornea and the lower eyelid then a built in software caliper tool was used to determine the borders of the tear meniscus and calculate the area (TMA) in millimeter square (mm2).

  6 months

Study Arms (2)

Patients planned to undergo Femtosecond laser FS assisted LASIK

ACTIVE COMPARATOR

In FS group, Allegretto WaveLight FS-200 femtosecond laser was used to create flaps with flap thickness planned to be 100 um.

Procedure: Laser in situ keratomileusis

Patients planned to undergo Microkeratome MK assisted LASIK

ACTIVE COMPARATOR

In MK group, Moria 2 Microkeratome was used to create flaps with flap thickness planned to be 100 um.

Procedure: Laser in situ keratomileusis

Interventions

Laser in situ keratomileusis PROCEDURE

Laser in situ keratomileusis LASIK is a procedure used to correct different types of ametropia through a creation of corneal flap whether with femtosecond laser or mechanically with a microkeratome followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism.

Patients planned to undergo Femtosecond laser FS assisted LASIK; Patients planned to undergo Microkeratome MK assisted LASIK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidates for Laser Vision Correction (LVC).
• Eyes with spherical equivalent (SE) up to - 10 diopters (D),
• Corneal thickness at thinnest location of ≥ 500 um and estimated postoperative residual stromal bed of at least 300 um

You may not qualify if:

• Patients with symptoms or signs of dry eye (TBUT \<10 sec, Schirmer I test \<10mm and Ocular Surface Disease Index OSDI score \>13),
• Posterior blepharitis, contact lens wearers ,
• Ocular surface disease ,
• Systemic diseases contraindicating LASIK and previous ocular surgery.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

TIBA eye center

Asyut, 71516, Egypt

Location

Related Publications (1)

• Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Dry eye after refractive surgery: a meta-analysis. Can J Ophthalmol. 2020 Apr;55(2):99-106. doi: 10.1016/j.jcjo.2019.07.005. Epub 2019 Aug 20.

  PMID: 31712000 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: June 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)