Comparing Posterior Release Sclerotomy With Conventional Evisceration Surgery.

NCT06962384 | Completed

• 1 other identifier: FUH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this interventional study is to compare posterior release sclerotomy in the scleral cup with conventional ball implantation during evisceration, focusing on intraoperative feasibility, postoperative outcomes, and implant stability. 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.
5. 5.Comparing patient satisfaction and quality of life measures.

Conditions

Evisceration; Ocular Trauma; Blind Painful Eye; Phthisis Bulbi; End Stage Glaucoma

Keywords

Evisceration; Ball implantation; Posterior release sclerotomy

Outcome Measures

Primary Outcomes (1)

• • Implant extrusion/migration rate within 6 months

  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)

• Patient satisfaction with implant motility

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

• 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

Study Arms (2)

Posterior Release Sclerotomy Group (PRS Group)

EXPERIMENTAL

A key advancement in evisceration techniques is posterior release sclerotomy within the scleral cup, which aims to expand the intraocular space and facilitate primary ball implantation. By creating a controlled posterior opening, this method is hypothesized to reduce intraoperative resistance to implant insertion, minimize excessive intraocular pressure, and decrease postoperative complications such as extrusion or exposure

Procedure: Posterior release sclerotomy

Conventional Ball Implantation Group (CBI Group)

EXPERIMENTAL

Conventional evisceration techniques involve creating a scleral incision to accommodate the ball implant, often requiring significant manipulation to fit the prosthesis securely. The resultant tight fit can lead to ischemic changes, delayed healing, and an increased risk of implant extrusion.

Procedure: Conventional Ball Implantation

Interventions

Posterior release sclerotomy PROCEDURE

* A 360-degree radial scleral incision was made, and an evisceration spoon was used to remove intraocular contents. * The scleral shell was cauterized to eliminate any residual uveal tissue. * Any remaining necrotic or inflamed tissue was debrided to ensure a clean surgical field and minimize postoperative complications. Posterior Release Sclerotomy Group (PRS Group) * A posterior sclerotomy (2-3 mm) was created at the posterior pole of the scleral shell using a crescent blade. * This sclerotomy expanded the intraocular space, reducing intraoperative resistance during implant insertion. * The spherical implant was gently placed within the expanded scleral shell, ensuring minimal stress on the tissue.

Posterior Release Sclerotomy Group (PRS Group)

Conventional Ball Implantation PROCEDURE

* A 360-degree radial scleral incision was made, and an evisceration spoon was used to remove intraocular contents. * The scleral shell was cauterized to eliminate any residual uveal tissue. * Any remaining necrotic or inflamed tissue was debrided to ensure a clean surgical field and minimize postoperative complications. * No posterior sclerotomy was performed. * The implant was inserted directly into the scleral cup, requiring greater force to accommodate the implant within the available space.

Conventional Ball Implantation Group (CBI Group)

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older
• Indication for evisceration due to a non-malignant cause, such as painful blind eye, severe ocular trauma, end-stage glaucoma, or phthisis bulbi
• Adequate scleral integrity to allow for ball implantation
• No history of previous intraocular surgery or scleral weakening disorders

You may not qualify if:

• Orbital malignancy or suspected intraocular tumor
• Active ocular or periocular infection
• History of radiation therapy to the orbit
• Severe scleral thinning that contraindicates scleral preservation
• Presence of autoimmune disease affecting wound healing
• Psychiatric disorders affecting compliance with postoperative care

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

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: May 1, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)