Comparison of Femtosecond Laser Assisted Cataract Surgery to Conventional Phacoemulsification Cataract Surgery
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.
|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|
- 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.
|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)|
Patients who undergo routine cataract surgery using conventional phacoemulsification technique
Patients who undergo femtosecond laser assisted cataract surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02096627
|Contact: Yassine Daoud, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University||Not yet recruiting|
|Baltimore, Maryland, United States, 21044|
|Principal Investigator: YASSINE DAOUD, MD|
|Principal Investigator:||yassine daoud, md||Johns Hopkins University|