Comparison of Femtosecond Laser Assisted Cataract Surgery to Conventional Phacoemulsification Cataract Surgery

Comparison of Femtosecond Laser Assisted Cataract Surgery to Conventional Phacoemulsification Cataract Surgery on Corneal Endothelial Cell Loss

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02096627

Enrollment

154

Registered

2014-03-26

Start date

2014-05-31

Completion date

2018-11-30

Last updated

2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Cataract, femtosecond laser, FLACS

Brief summary

In this project, the investigators aim to compare the safety, efficacy, and predictability outcomes of conventional CEIOL surgery to Femtosecond-laser-assisted CEIOL (FLACS) in an effort to improve cataract surgery outcomes. The investigators hypothesis is that FLACS may lead to preservation of endothelial cells compared to conventional CE IOL.

Detailed description

This study will only include patients who are eligible to undergo cataract surgery. All patients will receive treatment that is FDA approved for cataract surgery. Because all study participants will have been scheduled for elective cataract extraction regardless of their participation in this study, there will be little or no additional surgical risk associated with participation. A total of 720 patients are expected to be enrolled in the study during a period of 2 years. The investigators will recruit patients with bilateral operable cataracts. One eye will undergo cataract surgery using conventional cataract extraction technique including phacoemulsification whereas the second eye will undergo FLACS. No significant increased risk to the patient is expected in either arm of the study compared to routine cataract surgery. The patients will be examined as per previous post-operative cataract surgery guidelines on POD1, POW1, POM1, POM3, POM6, POY1 and POY2. The only treatment difference will take place at the time of the cataract surgery. Post-operatively, endothelial cell count will be obtained by the no-touch technology of specular microscopy at baseline as well as three months after surgery. If the study ends prematurely, the investigators do not anticipate any significant change in the care of the patient.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

1. Patients older than 18 years of age 2. Ability to understand and sign an informed consent 3. Visually significant cataract eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye 4. Ability and commitment to follow up for 18 months after surgery 5. No other ocular pathology and no previous/concurrent surgery

Exclusion criteria

1. Any other ocular pathology that may affect best-corrected visual acuity 2. Previous or concurrent ocular surgery 3. Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study. 4. Patients with keratoconus or keratectasia 5. Patients who are blind on one eye

Design outcomes

Primary

Measure	Time frame	Description
endothelial cell density three months after conventional CEIOL or FLACS compared to baseline	up to 2 years	endothelial cell density will be compared at baseline and three months after a patient undergoes FLACS or Conventional CE IOL to see which technique causes less endothelial cell loss.

Countries

United States

Outcome results