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

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

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).

Study Overview

• Status: Completed
• Conditions: Hydration; Cataract Surgery
• Intervention / Treatment: Procedure: Patient with visible central wound gap of the CCI

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Czechia
    • Pilsen, Czechia, Czechia, 30100
      • University Hospital Pilsen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• any other ocular pathology
• serious systhemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Central wound gap of 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.

Procedure: Patient 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
posterior flap hydration	The 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.	1 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal wound morphology on the first postoperative day	The 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 (%).	20-24 hours after surgery

Collaborators and Investigators

• Sponsor: University Hospital Pilsen

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cataract; clear corneal incision; wound hydration; posterior flap
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Posterior flap hydration

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No