Cataract SurgerySIPSIPNCT07821203
Subincisional Pockets for Sealing Clear Corneal Incisions in Cataract Surgery
An observational study of Cataract Surgery and Cataract (Post-operative Cataract Surgery Follow-up), run by Philippine Eye Research Institute at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract Surgery, Cataract (Post-operative Cataract Surgery Follow-up), Phacoemulsification Cataract Surgery
- What is being tested?
- Sub-Incisional Pocket
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Jan 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cataract Surgery, Cataract (Post-operative Cataract Surgery Follow-up), Phacoemulsification Cataract Surgery, Wound Closure Technique, Wound Closure
- Being tested
- Sub-Incisional Pocket
- Keywords
- Sub-Incisional Pocket, Cataract surgery, Phacoemulsification, wound seal, wound closure, wound closure technique
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-Incisional PocketProcedure or surgery
Also called Corneal Sub-Incisional Pocket, SIP
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Weeks
Change from 3 months pre-operation in astigmatism as measured by keratometry (diopter) at 6 weeks post-operation.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jan 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philippine Eye Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Peregrine Eye and Laser Institute, Ilocos Training and Regional Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821203
- Sponsor's protocol ID
- RGAO-2026-0520
- Acronym
- SIPSIP
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-Incisional Pockets for Sealing Phacoemulsification Incisions: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07821203
- Acronym / sponsor ID
- SIPSIP / RGAO-2026-0520
- Conditions
- Cataract Surgery, Cataract (Post-operative Cataract Surgery Follow-up), Phacoemulsification Cataract Surgery, Wound Closure Technique, Wound Closure
- Keywords
- Sub-Incisional Pocket, Cataract surgery, Phacoemulsification, wound seal, wound closure, wound closure technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Philippine Eye Research InstituteUniversity, hospital or other
- Collaborators
- Peregrine Eye and Laser Institute, Ilocos Training and Regional Medical Center
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sub-Incisional PocketAlso: Corneal Sub-Incisional Pocket, SIPThe 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. | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Surgery and Cataract (Post-operative Cataract Surgery Follow-up), run by Philippine Eye Research Institute at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.