Resident-Performed Laser-Assisted vs Manual Traditional Phacoemulsification Cataract Surgery

NCT02561104 | Completed

• 1 other identifier: STU 092014-020
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The study design will be a prospective study comparing laser-assisted cataract extraction cases and traditional manual phacoemulsification cases. All cases will be performed by faculty-supervised residents at Parkland Memorial Hospital. This study aims to examine visual acuity and complication rates in femtosecond laser-assisted cataract surgery compared to traditional manual phacoemulsification cataract surgery for the beginning surgeon. In addition, this study will assess the subjective novice surgeon experience and the patient experience in terms of expectations and results.

Conditions

Incipient Cataract; Senile Nuclear Sclerosis

Keywords

cataract; phacoemulsification; laser-assisted surgery; femtosecond laser

Outcome Measures

Primary Outcomes (2)

• Complication rates

  Complication and adverse event monitoring will occur at each visit: pre-operative, operative, post-op day 1, post-op day 7-14, post-op day 30-60 and 3 mos post-op

  Operative visit to last post-op visit at 3 mos

• Visual Acuity

  Bilateral best spectacle corrected visual acuity

  Change between baseline and 3 mos post-op.

Secondary Outcomes (5)

• Patient benefit perception

  Post-op day 1

• Patient benefit perception

  Post-op day 30-60

• Patient benefit perception

  3 mos post-op

• Corneal Endothelial Cell Count (ECC)

  Change from baseline to post-op day 30-60

• Lens removal time

  Operative visit

Study Arms (2)

LenSx

EXPERIMENTAL

Laser-assisted cataract surgery performed using the LenSx femtosecond laser.

Procedure: Laser-assisted cataract surgery.

Phaco

EXPERIMENTAL

Traditional manual phacoemulsification cataract surgery

Procedure: Traditional manual phacoemulsification

Interventions

Laser-assisted cataract surgery. PROCEDURE

LenSx

Traditional manual phacoemulsification PROCEDURE

Phaco

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred for cataract surgery at Parkland Memorial Hospital
• Potential post-operative visual acuity of 20/30 or greater determined by potential acuity meter (PAM) testing or modified super pinhole potential acuity of 20/30 or greater
• Clear intraocular media other than cataract in study eye(s)
• Subject eyes will have a dilated pupil diameter of at least 6 mm
• Subject eyes will lack other pre-existing ocular pathology or condition that may confound treatment effects, including diabetic retinopathy, previous retinal detachment, iris neovascularization, amblyopia, optic nerve atrophy or recurrent severe anterior or posterior segment inflammation of unknown etiology.

You may not qualify if:

• Severe corneal diseases or prior corneal surgery
• Active, significant external ocular or eyelid disease
• History of lens abnormalities including posterior polar cataract and zonular weakness precluding standard non-complex cataract surgery
• Retinal or posterior segment disease
• Advanced glaucoma, white or advanced cataract (precluding adequate examination of the posterior pole)
• Anatomic conditions that prevent placement of the femtosecond laser docking ring
• Corneal opacity that will interfere with the laser beam (hazy cornea)
• Presence of blood or materials in the anterior chamber
• Hypotony, advanced glaucoma, or presence of cornea implant
• Poor dilating pupil such that the iris is not peripheral to the intended diameter for the capsulotomy
• Condition which would cause inadequate clearance between the intended capsulotomy depth and the corneal endothelium
• Any contraindication to cataract or kerato-refractive surgery
• Contact lens wearers must discontinue the use of contacts for an appropriate period of time to ensure that their corneas are stable before screening measurements are performed. For rigid gas permeable (RGP) lenses, it is at least 2-4 weeks before accurate imaging measurements can be performed. Study doctor will assess patient findings and determine how long RGP lens wear must be discontinued prior to surgery. For soft contact lenses, it is at least 3 days prior to study measurements.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Brock Hansen, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 25, 2015
• Study Start: December 1, 2015
• Primary Completion: June 19, 2018
• Study Completion: June 19, 2018
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

US (1)