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Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye

Primary Purpose

Myopic LASIK Candidates With Spherical Equivalent up to - 10 Diopters

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser in situ keratomileusis
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic LASIK Candidates With Spherical Equivalent up to - 10 Diopters focused on measuring Dry eye, Femtolaser, Laser in situ keratomileusis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • TIBA eye center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients planned to undergo Femtosecond laser FS assisted LASIK

Patients planned to undergo Microkeratome MK assisted LASIK

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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)
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.
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).

Secondary Outcome Measures

Full Information

First Posted
March 31, 2021
Last Updated
April 2, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04831177
Brief Title
Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye
Official Title
Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The pathophysiology of post LASIK dry eye is not clear; however, many mechanisms have been suggested including inflammation, loss of conjunctival goblet cells during suction, exacerbation of a preexisting dry eye, abnormal interaction between the lid margins and the ocular surface. Intact corneal sensation is crucial for proper tear production and distribution on the ocular surface as well as maintaining the normal dynamics of eyelid blinking. Disruption of corneal nerves in LASIK decreases the release of neurotrophic factors necessary for the normal function of the corneal epithelium as well as the integrity of the lacrimal functional unit, a condition referred to as LASIK induced neurotrophic epitheliopathy (LINE) that largely contributes to the development of post- LASIK dry eye . Many studies evaluated the incidence of post-refractive dry eye after LASIK compared to flapless laser vision correction (LVC) procedures such as PRK and small incision lenticule extraction (SMILE). The aim of this study is to assess and compare different dry eye parameters following LASIK with planned thin flaps created by femtosecond laser (FS) and mechanical microkeratome (MK).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic LASIK Candidates With Spherical Equivalent up to - 10 Diopters
Keywords
Dry eye, Femtolaser, Laser in situ keratomileusis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients planned to undergo Femtosecond laser FS assisted LASIK
Arm Type
Active Comparator
Arm Description
In FS group, Allegretto WaveLight FS-200 femtosecond laser was used to create flaps with flap thickness planned to be 100 um.
Arm Title
Patients planned to undergo Microkeratome MK assisted LASIK
Arm Type
Active Comparator
Arm Description
In MK group, Moria 2 Microkeratome was used to create flaps with flap thickness planned to be 100 um.
Intervention Type
Procedure
Intervention Name(s)
Laser in situ keratomileusis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tear film break up time TBUT
Description
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
Time Frame
6 months
Title
Schirmer I test
Description
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.
Time Frame
6 months
Title
Ocular Surface Disease Index OSDI
Description
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)
Time Frame
6 months
Title
Lower Tear meniscus height (LTMH)
Description
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.
Time Frame
6 months
Title
Lower Tear meniscus area (LTMA)
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
TIBA eye center
City
Assiut
ZIP/Postal Code
71516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31712000
Citation
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.
Results Reference
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Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye

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