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Subincisional Pockets for Sealing Clear Corneal Incisions in Cataract Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07821203
Acronym
SIPSIP
Enrollment
35
Registered
2026-09-15
Start date
2025-01-01
Completion date
2026-02-28
Last updated
2026-09-15

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

Conditions

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

Keywords

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

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.

Interventions

PROCEDURESub-Incisional Pocket

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.

Sponsors

Philippine Eye Research Institute
Lead SponsorOTHER
Peregrine Eye and Laser Institute
CollaboratorOTHER
Ilocos Training and Regional Medical Center
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
Wound seal of participants assessed with the CCI-SIP 4-point ordinal scale by pressure with cotton tip pledget at post-operative day 1.6 WeeksClear 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.6 weeks

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026