Clinical trial NCT02492659: Clinical Research of Femtosecond Laser-Assisted Cataract Surgery
Official title: Clinical Research of Femtosecond Laser-Assisted Cataract Surgery: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: femtosecond laser
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 54
Sex: ALL
Minimum age (years): 38
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the proteins in the aqueous humor after femtosecond laser operation
timeFrame: day 1
Secondary outcomes:
measure: the electrolyte in the aqueous humor after femtosecond laser operation
timeFrame: day 1
measure: morphology of the anterior capsule after femtosecond laser operation
timeFrame: day 1
Other outcomes:
measure: phacoemulsification energy
timeFrame: in operation
measure: phacoemulsification time
timeFrame: in operation
measure: postoperative refraction
timeFrame: day 1,after one week
measure: the capsulorhexis size
timeFrame: after one month,after three month
measure: corneal endothelial density
timeFrame: after one month,after three month
Locations:
city: Wenzhou
country: China
facility: Eye Hispital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: A-Yong Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References: