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Posterior Flap Hydration of Clear Corneal Incisions in Cataract Surgery: Influence on Corneal Wound Tightness and Architecture

Posterior Flap Hydration of Clear Corneal Incisions: Influence on Wound Tightness and Architecture

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07581366
Acronym
CCI hydration
Enrollment
53
Registered
2026-05-12
Start date
2021-01-14
Completion date
2021-06-30
Last updated
2026-05-12

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

Conditions

Cataract Surgery, Hydration

Keywords

Cataract, clear corneal incision, wound hydration, posterior flap

Brief summary

Sutureless clear corneal incision (CCI) is the most commonly used technique for creating an entrance wound in cataract surgery. Corneal incision hydration enhances wound tightness and reduces postoperative fluid suction from the ocular surface into the anterior chamber; thereby, loweres the risk of postoperative endophthalmitis. Various hydration methods have been employed to close corneal incisions. Standard CCI hydration may be ineffective in sutureless incisions with central wound gaping. Authors described a new technique of hydration: a posterior flap hydration technique. This study evaluates its effect on corneal wound tightness immediately after hydration, and assess wound architecture on the first postoperative day using anterior segment optical coherence tomography (AS-OCT).

Detailed description

The study subjects are patients with uncomplicated cataracts, without other eye diseases and without diseases affecting wound healing (e.g. diabetes mellitus, rheumatoid arthritis, etc.), who have a visible central wound gap of the CCI at the end of the surgery.

Interventions

PROCEDUREPatient with visible central wound gap of the CCI

Patient with visible central wound gap of the CCI were treated with posterial flap hydration. Standard hydrodissection and hydrodelineation cannulas are used for hydration. Cannulas with flat ends, including the cortical cleaving hydrodissector 27 G × 7/8 (BVI Visitec) and a hydrodissector 27 G × 7/8 (Sterimedix Ltd.), are employed. The morphology of the central wound before and after hydration is evaluated using video recordings. On the first postoperative day (20-24 hours after surgery), anterior segment optical coherence tomography (AS-OCT) analysis of corneal incisions is performed with a Tomey Casia 2 device using the Post-op Cataract AS Global Scan application.

Sponsors

University Hospital Pilsen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* cataract * visible central wound gap of CCI at the end of the surgery

Exclusion criteria

* any other ocular pathology * serious systhemic diseases

Design outcomes

Primary

MeasureTime frameDescription
posterior flap hydration1 day after surgeryThe Primary Outcome Measure is to evaluate the tightness of the corneal wound after the posterior flap hydration peroperatively (at the end fo the surgery) - no leakage of the intraocular fluid schould by observed after the hydration.

Secondary

MeasureTime frameDescription
Corneal wound morphology on the first postoperative day20-24 hours after surgeryThe other Outcome Measure is the corneal wound morphology on the first postoperative day (20-24 hours after surgery) using anterior segment optical coherence tomography (AS-OCT). The corneal incision pathology (central wound gaping, posterior flap prominence, tongue eversion, tongue retraction and focal Descemet's membrane detachment ) will be serached on OCT pictures and their incidence among study patients will be reported as a percentage (%).

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026