Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye

NCT ID: NCT04831177

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-09-01

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).

Conditions

Myopic LASIK Candidates With Spherical Equivalent up to - 10 Diopters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patients planned to undergo Femtosecond laser FS assisted LASIK

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

Group Type: ACTIVE_COMPARATOR

Laser in situ keratomileusis

Intervention Type: 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 Microkeratome MK assisted LASIK

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

Group Type: ACTIVE_COMPARATOR

Laser in situ keratomileusis

Intervention Type: 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.

Interventions

Laser in situ keratomileusis

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abdel-Radi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

TIBA eye center

Asyut, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 31712000 (View on PubMed)

Other Identifiers

TFLADE

Identifier Type: -

Identifier Source: org_study_id