NCT02550353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

September 13, 2015

Last Update Submit

June 13, 2016

Conditions

MyopiaAstigmatism

Keywords

lenticule extractionfemtosecond laser-assisted laser in situ keratomileusistearinflammatory mediators

Outcome Measures

Primary Outcomes (12)

  • Schirmer I test

    up to 1month after surgery

  • corneal fluorescein staining

    up to 1month after surgery

  • noninvasive tear breakup time

    up to 1month after surgery

  • ocular surface disease index

    up to 1month after surgery

  • central corneal sensitivity

    up to 1month after surgery

  • tear meniscus height

    up to 1month after surgery

  • Interleukin-1α

    up to 1month after surgery

  • tumor necrosis factor-α

    up to 1month after surgery

  • nerve growth factor

    up to 1month after surgery

  • interferon-γ

    up to 1month after surgery

  • transforming growth factor-β1

    up to 1month after surgery

  • matrix metalloproteinase-9

    up to 1month after surgery

Secondary Outcomes (1)

  • Correlation Between Inflammatory Mediators and Ocular Surface Changes

    up to 1month after surgery

Study Arms (2)

lenticule extraction

EXPERIMENTAL

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

Procedure: lenticule extraction

FS assisted laser in situ keratomileusis

EXPERIMENTAL

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

Procedure: femtosecond laser-assisted laser in situ keratomileusis

Interventions

lenticule extractionPROCEDURE

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.

lenticule extraction
femtosecond laser-assisted laser in situ keratomileusisPROCEDURE

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.

FS assisted laser in situ keratomileusis

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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。

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Haikou, Hainan, 570311, China

Location

MeSH Terms

Conditions

MyopiaAstigmatismLacerations

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesWounds and Injuries

Study Officials

  • Xingwu Zhong, MD,PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

CN(1)