NCT07581366

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

April 23, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

Cataractclear corneal incisionwound hydrationposterior flap

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

EXPERIMENTAL

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

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.

Central wound gap of CCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

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

Locations