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OpenTrials
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NCT Number: NCT07581366

Posterior Flap Hydration of Clear Corneal Incisions in Cataract Surgery: Influence on Corneal 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).

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Key information

Conditions

Hydration Cataract Cataract Surgery Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Pilsen

Pilsen, Czechia, 30100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • any other ocular pathology
  • serious systhemic diseases

Treatment and study plan

Patient with visible central wound gap of the CCI

Procedure

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.

Primary outcomes

  1. posterior flap hydration

    Time frame: 1 day after surgery

    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.

Secondary outcomes

  1. Corneal wound morphology on the first postoperative day

    Time frame: 20-24 hours after surgery

    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 (%).

Sponsors and collaborators

Lead sponsor

University Hospital Pilsen

Other

Registry information

Official study title

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

Acronym: CCI hydration

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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