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IOP Changes Associated With SICS and Phako

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ClinicalTrials.gov Identifier: NCT02642211
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Robin, Alan L., M.D.

Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Glaucoma Procedure: cataract surgery Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Cataract

Arm Intervention/treatment
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




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


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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
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


Responsible Party: Robin, Alan L., M.D.
ClinicalTrials.gov Identifier: NCT02642211     History of Changes
Other Study ID Numbers: SICS_Phaco_1
First Posted: December 30, 2015    Key Record Dates
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