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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096627
• Other study ID #: NA_00089916
• Status: Completed
• Start date: May 2014
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Cell Loss

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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