Posterior Flap Hydration of Clear Corneal Incisions in Cataract Surgery: Influence on Corneal Wound Tightness and Architecture
CCI hydration
1 other identifier
interventional
53
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
April 23, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedMay 12, 2026
May 1, 2026
3 months
April 23, 2026
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Corneal wound morphology on the first postoperative day
20-24 hours after surgery
Study Arms (1)
Central wound gap of CCI
EXPERIMENTALPatient 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- cataract
- visible central wound gap of CCI at the end of the surgery
You may not qualify if:
- any other ocular pathology
- serious systhemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Pilsen
Pilsen, Czechia, 30100, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2026
First Posted
May 12, 2026
Study Start
January 14, 2021
Primary Completion
March 31, 2021
Study Completion
June 30, 2021
Last Updated
May 12, 2026
Record last verified: 2026-05