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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Yassine Daoud, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02096627
First received: March 16, 2014
Last updated: March 23, 2014
Last verified: March 2014
  Purpose

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.


Condition
Cataract

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Femtosecond Laser Assisted Cataract Surgery to Conventional Phacoemulsification Cataract Surgery on Corneal Endothelial Cell Loss

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • endothelial cell density three months after conventional CEIOL or FLACS compared to baseline [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 720
Study Start Date: May 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
conventional
Patients who undergo routine cataract surgery using conventional phacoemulsification technique
FLACS
Patients who undergo femtosecond laser assisted cataract surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who present to our center with visually significant cataract and who may benefit from cataract surgery

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096627

Contacts
Contact: Yassine Daoud, MD 4109102330 ydaoud1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21044
Principal Investigator: YASSINE DAOUD, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: yassine daoud, md Johns Hopkins University
  More Information

No publications provided

Responsible Party: Yassine Daoud, Asst Prof Ophthalmology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02096627     History of Changes
Other Study ID Numbers: NA_00089916
Study First Received: March 16, 2014
Last Updated: March 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Cataract, femtosecond laser, FLACS

Additional relevant MeSH terms:
Cataract
Corneal Endothelial Cell Loss
Lens Diseases
Eye Diseases
Corneal Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014