Clinical Research of Femtosecond Laser-Assisted Cataract Surgery (FLACS)

Clinical Research of Femtosecond Laser-Assisted Cataract Surgery: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Procedure: femtosecond laser-assisted cataract surgery; Procedure: conventional phacoemulsification

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Eye Hispital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. corneal pathological changes
2. glaucoma
3. ocular inflammation
4. previous ocular trauma or surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trial group; the trial group underwent femtosecond laser-assisted cataract surgery	Procedure: femtosecond laser-assisted cataract surgery; 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.
Other: control group; the control group underwent conventional phacoemulsification	Procedure: conventional phacoemulsification; continuous curvilinear capsulorhexis was performed with capsulorrhexis forceps. Following hydrodissection, phacoemulsification of the nucleus, aspiration of the residual cortex and capsular polishing were performed using a phacoemulsification machine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Time Frame
phacoemulsification energy	in operation
phacoemulsification time	in operation
postoperative refraction	day 1,after one week
the capsulorhexis size	after one month,after three month
corneal endothelial density	after one month,after three month

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Principal Investigator: A-Yong Yu, PhD, Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 8, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: femtosecond laser
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Femtosecond Laser