Resident-Performed Laser-Assisted vs Manual Traditional Phacoemulsification Cataract Surgery
Condition: Incipient Cataract; Senile Nuclear Sclerosis
MeSH terms: Cataract
Study type: Interventional

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.
    

Detailed description: 
      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. Cataract surgery training is a
      standard requirement of all ophthalmology residents who are part of this clinical study.

      Each resident must be a post graduate year 4 (PGY-4) level resident before being asked to be
      a part of this clinical study. Typically, each resident will have completed approximately 30
      cataract surgeries by their PGY-3 residency year of training. These traditional
      phacoemulsification require manual capsulorrhexis creation with which residents will have
      experience prior to study participation. Other critical manual surgical steps of traditional
      and femtosecond-laser assisted cataract surgery require similar surgical skill sets, thus
      residents should have surgical skills applicable to both techniques prior to study
      involvement.

      In addition to performing 30 traditional phacoemulsification surgeries, residents also will
      have assisted with femtosecond laser-assisted cases during their PGY-3 training year training
      at the Dallas VA medical center and with staff at University of Texas (UT) Southwestern
      Medical Center during their cornea rotation. The femtosecond-assisted cases completed by each
      resident in the study at Parkland will be the Alcon Certification cases for each resident.
      Performing femtosecond-laser assisted cases at this level of training will provide objective
      insights into this new surgical technique in resident hands. Patients will not be subjected
      to any additional risk due to participation in this study as femtosecond laser Alcon
      Certification is already being performed by residents as part of their standard UT
      Southwestern ophthalmology training.

      Patient eyes that meet the inclusion and exclusion criteria below will be randomly assigned
      to either the laser-assisted or the standard manual phacoemulsification group based.
      Following surgery, patients will return for post-operative visits at post-op day 1, post-op
      week 1, post-op month 1, and post-op month 3. Subjects will be followed in the Parkland
      Surgery Chief clinic. Subjects will not necessarily see the same study surgeon during each
      post-operative visit period. It should be noted this is the standard procedure as currently
      practiced in the Parkland ophthalmology clinic.

      Verification of subject adherence to the post-operative follow-up visit schedule will be
      overseen by the PI throughout the course of the project. Weekly communication with
      sub-investigators will take place in order to review any outstanding concerns including
      recruitment effort, surgery schedules, and post-operative visit timelines. Arrangements for
      additional visits will also be reviewed and scheduled if medically necessary depending on
      individual patients' post-operative clinical course. Patients will be assigned to each group
      during the period of September 2015 through July 2016 and followed as part of the study for 3
      months post-operatively.

      Patients will be offered the same kerato-refractive procedures including manual limbal
      relaxing incisions or LenSx astigmatic keratotomy that would be offered to patients who are
      not part of this study. Patients will also be evaluated for benefit from advanced technology
      intraocular lenses (Toric for astigmatism and ReStor multifocal) that patients who are not
      part of the study would be offered. Offering advanced technology lenses or combined
      kerato-refractive procedures is not expected to influence the visual acuity study outcomes
      for patients in this study. Patient's clinical history, past medical history and ophthalmic
      medical notes (in particular pre-operative evaluation, operative, and post-operative follow
      up) will be reviewed. De-identified data points will be extracted for this project.
    

Intervention name(s): Laser-assisted cataract surgery.; Traditional manual phacoemulsification
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cataract; phacoemulsification; laser-assisted surgery; femtosecond laser