Subincisional Pockets for Sealing Clear Corneal Incisions in Cataract Surgery

NCT07821203 | Completed

• 1 other identifier: RGAO-2026-0520
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Closure; Cataract Surgery; Cataract (Post-operative Cataract Surgery Follow-up); Phacoemulsification Cataract Surgery; Wound Closure Technique

Keywords

Sub-Incisional Pocket; Cataract surgery; Phacoemulsification; wound seal; wound closure; wound closure technique

Outcome Measures

Primary Outcomes (2)

• Wound seal of participants assessed with the CCI-SIP 4-point ordinal scale by pressure with cotton tip pledget at post-operative day 1.

  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.

  6 weeks

Interventions

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.

Also known as: Corneal Sub-Incisional Pocket, SIP

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Philippine Eye Research Institute: lead
• Peregrine Eye and Laser Institute: collaborator
• Ilocos Training and Regional Medical Center: collaborator

Study Sites (1)

Peregrine Eye and Laser Institute

Makati City, Philippines

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 15, 2026
• Study Start: January 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

PH (1)