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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 90
Updated:11/18/2018
Start Date:May 2014
End Date:November 2018

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

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.

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.

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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: YASSINE DAOUD, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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mi
from
Baltimore, MD
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