Subincisional Pockets for Sealing Clear Corneal Incisions in Cataract Surgery

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.

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Key information

Conditions

Cataract Surgery Cataract Cataract (Post-operative Cataract Surgery Follow-up) Eye Diseases Lens Diseases Phacoemulsification Cataract Surgery Wound Closure Wound Closure Technique

Sex eligibility

All sexes

Study type

Observational

Primary location

Peregrine Eye and Laser Institute

Makati City, Philippines

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sub-Incisional Pocket

Procedure

The sub-incisional pocket (SIP) consists of two (2) adjacent, non-penetrating, incisions using a 2.2 mm triangular blade placed just anterior to the limbus. This is followed by a penetrating clear corneal incision using the same 2.2 mm blade located immediately anterior to the SIP.

Other names: Corneal Sub-Incisional Pocket, SIP

Primary outcomes

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.
Change from 3 months pre-operation in astigmatism as measured by keratometry (diopter) at 6 weeks post-operation.

Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Philippine Eye Research Institute

Other

Collaborators

Ilocos Training and Regional Medical Center
Peregrine Eye and Laser Institute

Registry information

Official study title

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

Acronym: SIPSIP

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 15, 2026
Registry last updated: Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by invitation