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IOP Changes Associated With SICS and Phako

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02642211
First Posted: December 30, 2015
Last Update Posted: January 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robin, Alan L., M.D.
  Purpose
Prospective randomized trial in patients requiring cataract surgery in which IOP, angle anatomy and other demographic and clinical data are compared. Subjects randomized to both MSICS and phakoemulsification

Condition Intervention Phase
Cataract Glaucoma Procedure: cataract surgery Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: An Evaluation of Intraocular Pressure Reduction Following Phacoemulsification and Manual Small Incision Cataract Surgery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Robin, Alan L., M.D.:

Primary Outcome Measures:
  • Intraocular pressure lowering [ Time Frame: 6 months ]
    intraocular pressure measured with aplanation tonometry


Secondary Outcome Measures:
  • Angle anatomy [ Time Frame: 6 months ]
    OCT changes in angle anatomy


Enrollment: 500
Study Start Date: January 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: phako
eyes receiving phakoemulsification for cataract surgery
Procedure: cataract surgery
Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion
Active Comparator: MSICS
Eyes undergoing manual small incision cataract surgery
Procedure: cataract surgery
Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion

Detailed Description:
Prospective, randomized, double masked, parallel assignment clincal trial. Five hundred eyes of 500 participants between 40 - 70 years with normal IOP, gonioscopically open angles and age related cataract. Eyes underwent phacoemulsification or MSICS following a 1:1 randomization and allocation code. Best corrected vision (BCVA), IOP, comprehensive slit lamp evaluation and anterior segment optical coherence tomography (ASOCT) were performed at baseline and at 1, 3 and 6 months follow up.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Age over 40 requiring cataract surgery -

Exclusion Criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Robin, Alan L., M.D.
ClinicalTrials.gov Identifier: NCT02642211     History of Changes
Other Study ID Numbers: SICS_Phaco_1
First Submitted: December 19, 2015
First Posted: December 30, 2015
Last Update Posted: January 7, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: plan to share in paper form and at national meetings

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases