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

NCT02096627 | Completed

• 1 other identifier: NA_00089916
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Cataract, femtosecond laser, FLACS

Outcome Measures

Primary Outcomes (1)

• endothelial cell density three months after conventional CEIOL or FLACS compared to baseline

  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

Study Arms (2)

conventional

Patients who undergo routine cataract surgery using conventional phacoemulsification technique

FLACS

Patients who undergo femtosecond laser assisted cataract surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21044, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• yassine daoud, md

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2014
• First Posted: March 26, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

US (1)