NCT02492659

Clinical Research of Femtosecond Laser-Assisted Cataract Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 38 Years – 86 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cataracts

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2015-07-09
• Last updated: 2015-07-09

Locations

1 site across 1 country: China