- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02096627
Comparison of Femtosecond Laser Assisted Cataract Surgery to Conventional Phacoemulsification Cataract Surgery
November 15, 2018 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
154
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21044
- Johns Hopkins University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who present to our center with visually significant cataract and who may benefit from cataract surgery
Description
Inclusion Criteria:
- Patients older than 18 years of age
- Ability to understand and sign an informed consent
- Visually significant cataract eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye
- Ability and commitment to follow up for 18 months after surgery
- No other ocular pathology and no previous/concurrent surgery
Exclusion Criteria:
- Any other ocular pathology that may affect best-corrected visual acuity
- Previous or concurrent ocular surgery
- Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
- Patients with keratoconus or keratectasia
- Patients who are blind on one eye
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
conventional
Patients who undergo routine cataract surgery using conventional phacoemulsification technique
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FLACS
Patients who undergo femtosecond laser assisted cataract surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
endothelial cell density three months after conventional CEIOL or FLACS compared to baseline
Time Frame: 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.
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: yassine daoud, md, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
March 16, 2014
First Submitted That Met QC Criteria
March 23, 2014
First Posted (Estimate)
March 26, 2014
Study Record Updates
Last Update Posted (Actual)
November 16, 2018
Last Update Submitted That Met QC Criteria
November 15, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00089916
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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