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

NCT06636630 | Completed

• 1 other identifier: Fayoum university hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Evisceration; Traumatic, Eye

Keywords

Evisceration, Ball implants, Double flap technique, Quadruple flap technique.

Outcome Measures

Primary Outcomes (1)

• Evaluating the post-operative extrusion rates of the ball implant from the scleral shell

  The primary outcome measure was implant stability, assessed clinically and through imaging at 1, 3, and 6 months postoperatively to review any signs of implant migration or extrusion as well as signs of conjunctival erosion.

  Through study completion, an average of 6 months

Secondary Outcomes (3)

• Postoperative pain

  From enrollment to the end of the follow up period after 6 months

• Postoperative complications

  From enrollment to the end of the follow up period after 6 months

• Patient satisfaction with implant motility

  From enrollment to the end of the follow up period after 6 months

Study Arms (2)

Double scleral flap

EXPERIMENTAL

Double Flap Technique (Group A) A 360-degree peritomy will be performed to expose the underlying sclera. Following evisceration of the ocular contents, careful hemostasis will be achieved. Two muscular-tendinous flaps will be developed from the horizontal rectus 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

Quadruple scleral flap

EXPERIMENTAL

Quadruple flap technique involves creating four scleral flaps, which proponents argue provides a more robust framework for securing the implant. This technique is designed to enhance the integration of the implant with surrounding orbital structures, thereby potentially reducing the risk of exposure and improving cosmetic outcomes. The quadruple flap method is suggested to better preserve the orbital anatomy, allowing for superior distribution of volume and more natural prosthetic motility.

Procedure: Quadruple scleral flap

Interventions

Quadruple scleral flap PROCEDURE

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.

Quadruple scleral flap

Double scleral flap PROCEDURE

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.

Double scleral flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Diagnosed with conditions necessitating evisceration with implant
• Able to provide informed consent

You may not qualify if:

• Previous ocular surgery affecting orbital anatomy
• Systemic conditions influencing wound healing (e.g., diabetes, autoimmune disorders)
• Allergy to implant materials

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum university hospital

Al Fayyum, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of ophthalmology fayoum university

Model Details: The study will enroll patients requiring evisceration with implant placement due to conditions such as end-stage painful blind eye, intraocular tumors, or severe ocular trauma. Patients will be randomly assigned to one of two surgical techniques: Double Flap Technique (Group A) or Quadriple Flap Technique (Group B).

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 10, 2024
• Study Start: January 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)