Clinical Research of Femtosecond Laser-Assisted Cataract Surgery

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Procedure: femtosecond laser-assisted cataract surgery; Procedure: conventional phacoemulsification

• Registration Number: NCT02492659
• Lead Sponsor: Wenzhou Medical University

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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Study First Submitted: 2015-06-19
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-08
• Last Update Submitted: 2015-07-08
• Study First Posted: 2015-07-09
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
trial group	femtosecond laser-assisted cataract surgery	the trial group underwent femtosecond laser-assisted cataract surgery
control group	conventional phacoemulsification	the control group underwent conventional phacoemulsification

Primary Outcome Measures

Name	Time	Method
the proteins in the aqueous humor after femtosecond laser operation	day 1

Secondary Outcome Measures

Name	Time	Method
the electrolyte in the aqueous humor after femtosecond laser operation	day 1
morphology of the anterior capsule after femtosecond laser operation	day 1

Trial Locations

Locations (1)

Eye Hispital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China