IOP Changes Associated With SICS and Phako

An Evaluation of Intraocular Pressure Reduction Following Phacoemulsification and Manual Small Incision Cataract Surgery: A Randomized Controlled Trial

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02642211

Enrollment

500

Registered

2015-12-30

Start date

2014-01-31

Completion date

2015-09-30

Last updated

2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma

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

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.

Interventions

PROCEDUREcataract surgery

Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Age over 40 requiring cataract surgery -

Exclusion criteria

inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma \-

Design outcomes

Primary

Measure	Time frame	Description
Intraocular pressure lowering	6 months	intraocular pressure measured with aplanation tonometry

Secondary

Measure	Time frame	Description
Angle anatomy	6 months	OCT changes in angle anatomy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026