Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis

NCT ID: NCT02550353

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-05-31

Brief Summary

The aim is to evaluate the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.

Detailed Description

Over the past few years, laser in situ keratomileusis with a femtosecond laser-created flap (FS-LASIK)has been a popular ophthalmic procedure for the correction of refractive error. This first all-in-one FS-laser system was designed to perform the refractive lenticule extraction (ReLEx) procedures, femtosecond lenticule extraction (FLEx).They have the same feature: corneal flap.

Ocular surface disruption during corneal refractive surgery is commonly considered to be closely related to the development of dry eye. Multiple etiologies contribute to this ocular surface disruption, including the flap creation and stromal ablation involved in previous refractive surgery techniques. Corneal nerve damage has been considered the main cause of dry eye, due to disrupted afferent sensory nerves, reduced blink reflex, and increased tear evaporation leading to tear film instability. In addition, postoperative inflammatory mediator fluctuations are also a key factor related to ocular surface damage. Extensive research has described the effects of cytokines, chemokines and growth factors in modulating corneal wound healing, cell migration, and apoptosis on the ocular surface after refractive surgery.

This prospective clinical study is going to assess the short-term changes in ocular surface measures and tear inflammatory mediators after lenticule extraction (FLEx) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) procedures.

Conditions

Myopia; Astigmatism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lenticule extraction

The patients in this group chose to receive the lenticule extraction surgery

Group Type: EXPERIMENTAL

lenticule extraction

Intervention Type: PROCEDURE

Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction was released, the flap was opened using a thin, blunt spatula and the free refractive lenticule was subsequently grasped with a forceps and extracted, after which the flap was repositioned carefully.

FS assisted laser in situ keratomileusis

The patients in this group chose to receive the femtosecond laser-assisted laser in situ keratomileusis surgery.

Group Type: EXPERIMENTAL

femtosecond laser-assisted laser in situ keratomileusis

Intervention Type: PROCEDURE

track distance and spot distance were 3.0 μm during flap creation and 1.5 μm during flap side-cutting. The flap diameter was 8.0 mm, and flap thickness was set to 105 μm. Side-cut angle and hinge angle were 90°and 50° respectively. The flaps were created by laser scanning in spirals from the periphery to the center of the pupil. An excimer laser system was used in the subsequent ablation of the stromal bed with a 6.0 mm optical zone. Once the excimer ablation was completed, the flap was repositioned in a similar fashion as in routine LASIK.

Interventions

femtosecond laser-assisted laser in situ keratomileusis

track distance and spot distance were 3.0 μm during flap creation and 1.5 μm during flap side-cutting. The flap diameter was 8.0 mm, and flap thickness was set to 105 μm. Side-cut angle and hinge angle were 90°and 50° respectively. The flaps were created by laser scanning in spirals from the periphery to the center of the pupil. An excimer laser system was used in the subsequent ablation of the stromal bed with a 6.0 mm optical zone. Once the excimer ablation was completed, the flap was repositioned in a similar fashion as in routine LASIK.

Intervention Type: PROCEDURE

lenticule extraction

Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction was released, the flap was opened using a thin, blunt spatula and the free refractive lenticule was subsequently grasped with a forceps and extracted, after which the flap was repositioned carefully.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• minimum age of 18 years(range from 18 year to 25 years)
• corneal thickness 500 μm with calculated residual stromal bed after treatment greater than 300 μm
• preoperative spherical equivalent refraction between- 2.00 diopter (D) and -6.50 D.preoperative cylindrical equivalent refraction between -0.25 D and -1.50 D.
• preoperative corneal curvature from 41.0 D to 46.0 D with a regular topographic pattern monocular best corrected visual acuity of 20/20 or better and stable refractive error (less than 0.5 D change) for 24 months before surgery。

Exclusion Criteria

• systemic disease that contraindicated the surgery (such as diabetes, glaucoma and systemic collagen vascular disease)
• corneal abnormality or disease.
• a history of tear supplement usage or contact lens wear during the past year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xingwu Zhong, MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingwu Zhong, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Locations

Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Haikou, Hainan, China

Countries

China

Other Identifiers

2015-002

Identifier Type: -

Identifier Source: org_study_id