Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT04733846
Collaborator
(none)
10
1
20.6
0.5

Study Details

Study Description

Brief Summary

Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.

This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.

Condition or Disease Intervention/Treatment Phase
  • Other: data collection

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.
Actual Study Start Date :
Mar 18, 2020
Actual Primary Completion Date :
Dec 5, 2020
Actual Study Completion Date :
Dec 5, 2021

Arms and Interventions

Arm Intervention/Treatment
corneal trauma sutured with Vicryl 10-0 monofilament

corneal trauma sutured with Vicryl 10-0 monofilament will be included. They will have data collection of medical records.

Other: data collection
Collection of clinical and paraclinical data during preoperative consultation Collection of clinical and paraclinical data during post-operative consultations Tele-consultation to determine if criteria for good healing / adherence, treatment tolerance / response to questions Remote follow-up 6 and 12 months after the trauma

Outcome Measures

Primary Outcome Measures

  1. change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention [Months: 0, 2, 6, 12, 18]

    Collected in the medical record.

  2. change Visual acuity (Parinaud scale) from baseline and 2, 6, 12 and 18 months after the intervention [Months: 0, 2, 6, 12, 18]

    Collected in the medical record.

Secondary Outcome Measures

  1. Astigmatism (diopter) [Months: 0, 2, 6, 12, 18]

    Collected in the medical record. Measured by OCT-TOMEY-CASIA).

  2. Number of postoperative external consultations [Months: 0, 2, 6, 12, 18]

    Collected in the medical record.

  3. Adverse events [Months: 0, 2, 6, 12, 18]

    Collected in the medical record. All adverse events connecting to the eye surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Corneal penetrating injury and/or lamellar laceration
Exclusion Criteria:
  • Corneal Penetrating injury trauma requiring necessarily ONLY Nylon 10-0

  • Traumatism requiring necessarily a cryopreserved human amniotic membrane (for example)

  • Traumatism eligible for biological glue (long-axis wound < 2 mm)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Saint-Etienne Saint-Étienne France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Thibaut GARCIN, MD PhD, CHU de Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT04733846
Other Study ID Numbers:
  • IRBN202021/CHUSTE
First Posted:
Feb 2, 2021
Last Update Posted:
Mar 29, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022