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

Wenzhou Medical University

Status: Completed

Conditions: Cataracts

Treatments: Procedure: femtosecond laser-assisted cataract surgery; Procedure: conventional phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT02492659

Femtosecond Laser

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 38 to 86 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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54 participants in 2 patient groups

trial group

Experimental group

Description:

the trial group underwent femtosecond laser-assisted cataract surgery

Treatment:

Procedure: femtosecond laser-assisted cataract surgery

control group

Other group

Description:

the control group underwent conventional phacoemulsification

Treatment:

Procedure: conventional phacoemulsification