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Early Changes Among FLEx, LASIK and FS-LASIK

NCT02551796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2016-06-14

No results posted yet for this study

Summary

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

Conditions

  • Myopia
  • Astigmatism

Interventions

PROCEDURE

lenticule extraction

Four femtosecond incisions will be 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 is released, the flap will be opened using a thin, blunt spatula and the free refractive lenticule will be subsequently grasped with a forceps and extracted, after which the flap will be repositioned carefully.

PROCEDURE

laser in situ keratomileusis

During LASIK surgery, the eye will be gently proptosed and a hinged corneal flap will be cut using a microkeratome. The flap will be lifted and the stromal bed will receive a 6 mm diameter and stroma ablation. Finally reposition the flap carefully.

PROCEDURE

FS assisted laser in situ keratomileusis

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xingwu Zhong · Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
31 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02551796 on ClinicalTrials.gov