Clinical Research of Femtosecond Laser-Assisted Cataract... | NCT02492659

Studies
Clinical Research of Femtosecond Laser-Assisted Cataract Surgery

NCT02492659

Sponsor

Wenzhou Medical University

Status

Completed

Last Update Posted

Jul 9, 2015Estimated

Enrollment

54Actual

Phase

Not Applicable

Conditions

Cataracts

Interventions

femtosecond laser-assisted cataract surgery
conventional phacoemulsification

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jun 19, 2015

First Submission Date that Met QC Criteria

Jul 8, 2015

First Posted Date

Jul 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2015

Last Update Posted Date

Jul 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

A-Yong Yu, clinical professor, Wenzhou Medical UniversityPrincipal Investigator

Lead Sponsor

Wenzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Since femtosecond laser was approved for cataract surgery by FDA in 2010, femtosecond laser assisted cataract surgery (FLACS) has demonstrated high precision of capsulotomy, reduced phacoemulsification power and time, and comparable refractive outcome in clinic.

It is still unknown whether there are toxic substances produced due to photochemical or high-energy physical effect of femtosecond laser during FLACS.

Detailed Description

Phacoemulsification is one of the main surgical procedures for cataract surgery owing to the advantages of small incisions and rapid recovery. However, the surgical outcome of phacoemulsification can be negatively affected due to the problem of accuracy and repeatability for capsulorhexis, and the corneal endothelial cell damage by ultrasound energy.To overcome those problems from the phacoemulsification, femtosecond laser-assisted cataract surgery (FLACS) had been used in the past few years and showed unique advantages.

The purpose of this study is to investigate the preliminary clinical outcomes of femtosecond laser-assisted cataract surgery.This prospective comparative study enrolled consecutive patients,will be randomly assigned to trial group underwent FLACS and control group underwent conventional cataract surgery.

The phacoemulsification time, energy, and complications during operation were recorded.

The anterior capsule and aqueous humor were collected. Morphology of the cutting edge and cells of anterior capsule was assessed by light microscopy. The proteins in the aqueous humor were identified by mass spectrometry . Electrolyte in the aqueous humor was detected by a chemistry analyzer. Postoperative refraction at 1 day, 1 week, 1 and 3 months, the capsulorhexis size and corneal endothelial density at 1 and 3 months were also measured.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
trial group	Experimental	the trial group underwent femtosecond laser-assisted cataract surgery	Procedure: femtosecond laser-assisted cataract surgery
control group	Other	the control group underwent conventional phacoemulsification	Procedure: conventional phacoemulsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
femtosecond laser-assisted cataract surgery	Procedure	the femtosecond laser platform was used to generate capsulotomy with a diameter as described above in the control group, and lens fragmentation into 6 segments.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the proteins in the aqueous humor after femtosecond laser operation		day 1

Secondary Outcomes

Measure	Description	Time Frame
the electrolyte in the aqueous humor after femtosecond laser operation		day 1
morphology of the anterior capsule after femtosecond laser operation		day 1

Other Outcomes

Measure	Description	Time Frame
phacoemulsification energy		in operation
phacoemulsification time		in operation
postoperative refraction

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal cornea
dilated pupillary diameter greater than 6mm
no local or systemic contraindications to cataract surgery

Exclusion Criteria:

corneal pathological changes
glaucoma
ocular inflammation
previous ocular trauma or surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Years

Maximum Age

86 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
A-Yong Yu, PhD	Wenzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hispital of Wenzhou Medical University		Wenzhou	Zhejiang	325000	China

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided