IOP Changes Associated With SICS and Phako

Robin, Alan L., M.D.

Status and phase: Completed; Early Phase 1

Conditions: Cataract; Glaucoma

Treatments: Procedure: cataract surgery

Study type: Interventional

Identifiers

NCT02642211

SICS_Phaco_1

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Age over 40 requiring cataract surgery -

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

phako

Active Comparator group

Description:

eyes receiving phakoemulsification for cataract surgery

Treatment:

Procedure: cataract surgery

MSICS

Active Comparator group

Description:

Eyes undergoing manual small incision cataract surgery

Treatment:

Procedure: cataract surgery