Clinical Research of Femtosecond Laser-Assisted Cataract Surgery

Cataracts Clinical Trial

— FLACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492659
• Other study ID #: Femtosecond Laser
• Status: Completed
• Phase: N/A
• First received: June 19, 2015
• Last updated: July 8, 2015
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 38 Years to 86 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Eye Hispital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	phacoemulsification energy		in operation	No
Other	phacoemulsification time		in operation	No
Other	postoperative refraction		day 1,after one week	No
Other	the capsulorhexis size		after one month,after three month	No
Other	corneal endothelial density		after one month,after three month	No
Primary	the proteins in the aqueous humor after femtosecond laser operation		day 1	No
Secondary	the electrolyte in the aqueous humor after femtosecond laser operation		day 1	No
Secondary	morphology of the anterior capsule after femtosecond laser operation		day 1	No