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OpenTrials
Completed

NCT Number: NCT04733846

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

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.

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Key information

Conditions

Eye Trauma Craniocerebral Trauma Eye Diseases Eye Injuries Facial Injuries Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Penetrating

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Data Collection

Other

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

Primary outcomes

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

    Time frame: 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

    Time frame: Months: 0, 2, 6, 12, 18

    Collected in the medical record.

Secondary outcomes

  1. Astigmatism (diopter)

    Time frame: Months: 0, 2, 6, 12, 18

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

  2. Number of postoperative external consultations

    Time frame: Months: 0, 2, 6, 12, 18

    Collected in the medical record.

  3. Adverse events

    Time frame: Months: 0, 2, 6, 12, 18

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 2, 2021
Registry last updated
Mar 29, 2022

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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