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

NCT02550353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2016-06-14

No results posted yet for this study

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.

Conditions

  • Myopia
  • Astigmatism

Interventions

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xingwu Zhong, MD,PhD · 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
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2016-05-31

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 NCT02550353 on ClinicalTrials.gov