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NCT Number: NCT02492659

Clinical Research of Femtosecond Laser-Assisted Cataract Surgery

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.

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Key information

Age range

38 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • normal cornea
  • dilated pupillary diameter greater than 6mm
  • no local or systemic contraindications to cataract surgery

Exclusion criteria

  • corneal pathological changes
  • glaucoma
  • ocular inflammation
  • previous ocular trauma or surgery

Treatment and study plan

Femtosecond laser-assisted cataract surgery

Procedure

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

Procedure

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

Primary outcomes

  1. the proteins in the aqueous humor after femtosecond laser operation

    Time frame: day 1

Secondary outcomes

  1. the electrolyte in the aqueous humor after femtosecond laser operation

    Time frame: day 1

  2. morphology of the anterior capsule after femtosecond laser operation

    Time frame: day 1

Other outcomes

  1. phacoemulsification energy

    Time frame: in operation

  2. phacoemulsification time

    Time frame: in operation

  3. postoperative refraction

    Time frame: day 1,after one week

  4. the capsulorhexis size

    Time frame: after one month,after three month

  5. corneal endothelial density

    Time frame: after one month,after three month

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

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

Acronym: FLACS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2015
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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