Subincisional Pockets for Sealing Clear Corneal Incisions in Cataract Surgery (SIPSIP)

September 10, 2026 updated by: Philippine Eye Research Institute

Sub-Incisional Pockets for Sealing Phacoemulsification Incisions: A Retrospective Cohort Study

The main goal of the sub-incisional pocket (SIP) is to provide a wound seal option during corneal surgery. This retrospective cohort study aims to report the efficacy and safety of SIP among eyes undergoing routine cornea surgery as well as to determine factors that could be correlated with wound seal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Sub-Incisional Pocket

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Philippines
- - Makati City, Philippines
    - Peregrine Eye and Laser Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients that have undergone phacoemulsification with the sub-incisional pocket (SIP) from the Peregrine Eye and Laser Institute within the set study period of January 1, 2025 to February 28, 2026.

Description

Inclusion Criteria:

Adult (≥18 years) participants
Patients undergoing primary phacoemulsification with clear corneal incision and in-the-bag intraocular acrylic lens
Uncomplicated cataract surgeries utilizing a 2.2 mm temporal clear corneal incision with sub-incisional stromal pocket.

Exclusion Criteria:

Medical records from patients with intraoperative complications requiring incisions or suturing
Prior surgery in the operative eye
Prior corneal disease or ocular surface disease
With an inadequate follow-up within 7 days after surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound seal of participants assessed with the CCI-SIP 4-point ordinal scale by pressure with cotton tip pledget at post-operative day 1. Time Frame: 6 Weeks	Clear corneal incision-Subincisional pocket (CCI-SIP) wound seals were graded on a 4-point ordinal scale: Grade 4, Fully formed AC after removal of all instrumentation with no hydration maneuvers; Grade 3, Flat AC after instrumentation removal, AC reformed after hydrating the side-port incisions only; Grade 2, Flat AC reformed after hydrating both side ports and SIP; and Grade 1, flat AC reformed after hydrating the side ports, SIP and CCI lateral walls. A higher wound grade denotes better wound sealability.	6 Weeks
Change from 3 months pre-operation in astigmatism as measured by keratometry (diopter) at 6 weeks post-operation. Time Frame: 6 weeks		6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philippine Eye Research Institute

Collaborators

Ilocos Training and Regional Medical Center

Peregrine Eye and Laser Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)