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Comparing Posterior Release Sclerotomy With Conventional Evisceration Surgery.

NCT06962384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-03

No results posted yet for this study

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. 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.
5. Comparing patient satisfaction and quality of life measures.

Conditions

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

Interventions

PROCEDURE

Posterior release sclerotomy

* 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.

PROCEDURE

Conventional Ball Implantation

* 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.

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
2024-05-01
Primary Completion
2025-04-28
Completion
2025-04-28

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 NCT06962384 on ClinicalTrials.gov