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Comparing Double VS Quadruple Flap for Securing Ball Implants After Eye Ball Evisceration

NCT06636630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-10

No results posted yet for this study

Summary

The primary objective of this interventional study is to compare the efficacy and outcomes of the double flap and quadruple flap closure techniques in securing ball implants after evisceration. Specific objectives include:

1. Assessing the rate of implant migration and extrusion.
2. Evaluating the long-term stability of the implant within the scleral shell.
3. Investigating the occurrence of complications such as exposure or infection.
4. Analyzing the functional and anatomical outcomes of the closure techniques.
5. Comparing patient satisfaction and quality of life measures.

Conditions

  • Evisceration; Traumatic, Eye

Interventions

PROCEDURE

Quadruple scleral flap

Quadruple Flap Technique (Group B) A 360-degree peritomy will be performed to expose the underlying sclera. Following evisceration of the ocular contents, careful hemostasis will be achieved. Four muscular-tendinous flaps will be developed from the recti muscles. These flaps will be dissected under minimal tension to preserve their vascular supply. The prepared flaps will be draped over the implant in a manner that the edges slightly overlap, ensuring complete coverage. The flaps will be sutured together using silk sutures, securing the implant in place.The conjunctiva will be meticulously closed over the muscle flaps with continuous absorbable sutures to enhance the healing process and minimize postoperative discomfort.

PROCEDURE

Double scleral flap

The double flap technique, which involves the creation of two scleral flaps to encase and secure the implant, has been a standard approach in many surgical settings. This method aims to cover the implant adequately, thereby minimizing exposure risks and enhancing the potential for implant motility.

Sponsors & Collaborators

  • Fayoum University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06636630 on ClinicalTrials.gov