Comparative Analysis of Posterior Release Sclerotomy vs Conventional Ball Implantation in Evisceration Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fayoum University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- • Implant extrusion/migration rate within 6 months
Study Overview
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:
- Assessing the rate of implant migration and extrusion.
- Evaluating the long-term stability of the implant within the scleral shell.
- Investigating the occurrence of complications such as exposure or infection.
- Analyzing the functional and anatomical outcomes.
- Comparing patient satisfaction and quality of life measures.
Detailed Description
Evisceration is a widely performed ocular procedure aimed at removing intraocular contents while preserving the scleral shell and extraocular muscles. The primary goal of evisceration is to provide a structurally stable orbital implant, ensuring optimal prosthetic motility and cosmetic appearance. Traditional evisceration with ball implantation often presents complications related to limited space within the scleral cavity, potentially leading to implant extrusion or migration.
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. However, comparative studies on the effectiveness of posterior release sclerotomy versus conventional ball implantation remain limited.
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. In contrast, posterior release sclerotomy allows for better distribution of intraocular pressure and improved accommodation of the implant, potentially reducing postoperative complications.
Several studies have highlighted the importance of scleral integrity and orbital volume restoration in optimizing prosthetic movement and overall aesthetic outcomes. Ensuring adequate implant placement without undue pressure on the scleral shell is a crucial factor in preventing long-term complications such as conjunctival dehiscence or implant migration. Posterior release sclerotomy may offer a surgical advantage by providing additional space for implantation, reducing undue pressure, and preserving the scleral integrity.
Despite these theoretical advantages, clinical evidence comparing posterior release sclerotomy with conventional ball implantation remains scarce. Previous retrospective studies suggest that modified techniques may enhance surgical ease and reduce complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Posterior Release Sclerotomy Group (PRS Group)
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
Intervention: Posterior release sclerotomy (Procedure)
Conventional Ball Implantation Group (CBI Group)
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.
Intervention: Conventional Ball Implantation (Procedure)
Outcomes
Primary Outcomes
• Implant extrusion/migration rate within 6 months
Time Frame: Through study completion, an average of 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.
Secondary Outcomes
- 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)
Investigators
Khaled Kotb Abdallah
Lecturer of ophthalmology fayoum university
Fayoum University Hospital