Evisceration; Traumatic, EyeNCT06636630
Comparing Double VS Quadruple Flap for Securing Ball Implants After Eye Ball Evisceration
A study testing Quadruple scleral flap and Double scleral flap in people with Evisceration; Traumatic, Eye, run by Fayoum University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evisceration; Traumatic, Eye
- What is being tested?
- Quadruple scleral flap and Double scleral flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosed with conditions necessitating evisceration with implant
- Able to provide informed consent
Who cannot join
- Previous ocular surgery affecting orbital anatomy
- Systemic conditions influencing wound healing (e.g., diabetes, autoimmune disorders)
- Allergy to implant materials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Double Flap Versus Quadruple Flap Techniques in Stabilizing Ball Implants Post-Evisceration: a Comparative Analysis
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:
- 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 of the closure techniques.
- Comparing patient satisfaction and quality of life measures.
Read the detailed description
The choice of surgical technique for stabilizing ball implants following evisceration has a significant impact on both functional and aesthetic outcomes for patients. Evisceration, a procedure that involves the removal of intraocular contents while preserving the scleral shell and extraocular muscles, is typically performed to alleviate pain in a blind eye, prevent sympathetic ophthalmia, or improve the cosmetic appearance of a disfigured eye (Shields et al. 2022). Ball implants are commonly used to restore the anatomic integrity and appearance of the orbit post-evisceration, but their success largely depends on the stability provided by the surgical technique employed (Wang et al. 2023).
Recent advancements in oculoplastic surgery have introduced several techniques to enhance implant stability, with the double flap and quadruple flap methods gaining particular attention. The double flap technique involves the use of two scleral flaps to secure the implant, while the quadruple flap method utilizes four flaps to provide greater coverage and stability (Singh et al. 2023). Despite the increasing popularity of these techniques, there remains a lack of consensus regarding their relative efficacy in ensuring implant stability and minimizing complications, such as migration, exposure, or extrusion of the implant (Patel et al. 2023).
Some studies suggest that the quadruple flap technique offers superior stability due to increased tissue coverage, potentially reducing the risk of postoperative complications (Gonzalez et al. 2024). However, other research indicates that the double flap technique is equally effective, with the added benefit of reduced operative time and fewer intraoperative adjustments (Harrison et al. 2023). Given these conflicting findings, there is a clear need for further investigation to determine the most effective approach for stabilizing ball implants post-evisceration.
This study aims to evaluate and compare the efficacy of the double flap and quadruple flap techniques in stabilizing ball implants following evisceration.
Patients and Methods This prospective, randomized, controlled trial was conducted at the Department of Ophthalmic Surgery, Faculty of Medicine, Fayoum University during the period from January 2024 to July 2024. Approval was granted by the institutional ethics committee, adhered to the tenets of the Declaration of Helsinki and informed consent was secured from all participants.
Participants included patients requiring evisceration with implant placement due to conditions such as end-stage painful blind eye and endophthalmitis. All participants were randomly assigned to undergo either the Quadruple Flap Technique (Group A) or the Double Flap Technique (Group B). Eligible participants were 18 years or older, diagnosed with conditions necessitating evisceration with implant placement, and able to provide informed consent. Patients with previous ocular surgeries affecting orbital anatomy, systemic conditions influencing wound healing, or allergies to implant materials were excluded from the study.
Initial Assessment and Diagnostic Testing All patients underwent an initial consultation, which included a comprehensive medical and ocular history to identify any risk factors that could impact the surgery or the choice of implant, such as prior ocular procedures, systemic diseases, or allergies. A thorough physical examination was conducted, with a focus on the ocular area to assess the condition of the eye and surrounding tissues. Ultrasound was used to assess the integrity of the ocular structures, plan implant size and confirm the diagnosis.
Ophthalmic Assessment and Patient Counseling Each patient received a comprehensive ophthalmic assessment, which involved documentation of any remaining visual function, examination of the eyelids, conjunctiva, and cornea, and measurement of intraocular pressure to evaluate overall eye health. Silicone implant was used for all patients, and the appropriate size and shape of the implant were determined based on the patient's orbital volume and anatomy. Counseling sessions were conducted to provide detailed information about the selected surgical procedure, its risks and benefits, and postoperative expectations. Written informed consent was obtained from all participants after ensuring they fully understood the procedure and had the opportunity to ask questions.
- Conditions
- Evisceration; Traumatic, Eye
- Being tested
- Quadruple scleral flap, Double scleral flap
- Keywords
- Evisceration, Ball implants, Double flap technique, Quadruple flap technique.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadruple scleral flapProcedure or surgery
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.
Double scleral flapProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Quadruple scleral flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months
Secondary outcomes (3)
Postoperative pain
The Quality of Life (VAS) Score was determined using a Visual Analog Scale,
Measured: From enrollment to the end of the follow up period after 6 months
Postoperative complications
Measured: From enrollment to the end of the follow up period after 6 months
Patient satisfaction with implant motility
Assessed through a standardized questionnaire.
Measured: From enrollment to the end of the follow up period after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Jan 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evisceration; Traumatic, EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Kotb Abdallah, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636630
- Sponsor's protocol ID
- Fayoum university hospital
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Double Flap Versus Quadruple Flap Techniques in Stabilizing Ball Implants Post-Evisceration: a Comparative Analysis
- ClinicalTrials.gov ID
- NCT06636630
- Acronym / sponsor ID
- Fayoum university hospital
- Conditions
- Evisceration; Traumatic, Eye
- Keywords
- Evisceration, Ball implants, Double flap technique, Quadruple flap technique.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 of the closure techniques.
- Comparing patient satisfaction and quality of life measures.
Detailed description
The choice of surgical technique for stabilizing ball implants following evisceration has a significant impact on both functional and aesthetic outcomes for patients. Evisceration, a procedure that involves the removal of intraocular contents while preserving the scleral shell and extraocular muscles, is typically performed to alleviate pain in a blind eye, prevent sympathetic ophthalmia, or improve the cosmetic appearance of a disfigured eye (Shields et al. 2022). Ball implants are commonly used to restore the anatomic integrity and appearance of the orbit post-evisceration, but their success largely depends on the stability provided by the surgical technique employed (Wang et al. 2023).
Recent advancements in oculoplastic surgery have introduced several techniques to enhance implant stability, with the double flap and quadruple flap methods gaining particular attention. The double flap technique involves the use of two scleral flaps to secure the implant, while the quadruple flap method utilizes four flaps to provide greater coverage and stability (Singh et al. 2023). Despite the increasing popularity of these techniques, there remains a lack of consensus regarding their relative efficacy in ensuring implant stability and minimizing complications, such as migration, exposure, or extrusion of the implant (Patel et al. 2023).
Some studies suggest that the quadruple flap technique offers superior stability due to increased tissue coverage, potentially reducing the risk of postoperative complications (Gonzalez et al. 2024). However, other research indicates that the double flap technique is equally effective, with the added benefit of reduced operative time and fewer intraoperative adjustments (Harrison et al. 2023). Given these conflicting findings, there is a clear need for further investigation to determine the most effective approach for stabilizing ball implants post-evisceration.
This study aims to evaluate and compare the efficacy of the double flap and quadruple flap techniques in stabilizing ball implants following evisceration.
Patients and Methods This prospective, randomized, controlled trial was conducted at the Department of Ophthalmic Surgery, Faculty of Medicine, Fayoum University during the period from January 2024 to July 2024. Approval was granted by the institutional ethics committee, adhered to the tenets of the Declaration of Helsinki and informed consent was secured from all participants.
Participants included patients requiring evisceration with implant placement due to conditions such as end-stage painful blind eye and endophthalmitis. All participants were randomly assigned to undergo either the Quadruple Flap Technique (Group A) or the Double Flap Technique (Group B). Eligible participants were 18 years or older, diagnosed with conditions necessitating evisceration with implant placement, and able to provide informed consent. Patients with previous ocular surgeries affecting orbital anatomy, systemic conditions influencing wound healing, or allergies to implant materials were excluded from the study.
Initial Assessment and Diagnostic Testing All patients underwent an initial consultation, which included a comprehensive medical and ocular history to identify any risk factors that could impact the surgery or the choice of implant, such as prior ocular procedures, systemic diseases, or allergies. A thorough physical examination was conducted, with a focus on the ocular area to assess the condition of the eye and surrounding tissues. Ultrasound was used to assess the integrity of the ocular structures, plan implant size and confirm the diagnosis.
Ophthalmic Assessment and Patient Counseling Each patient received a comprehensive ophthalmic assessment, which involved documentation of any remaining visual function, examination of the eyelids, conjunctiva, and cornea, and measurement of intraocular pressure to evaluate overall eye health. Silicone implant was used for all patients, and the appropriate size and shape of the implant were determined based on the patient's orbital volume and anatomy. Counseling sessions were conducted to provide detailed information about the selected surgical procedure, its risks and benefits, and postoperative expectations. Written informed consent was obtained from all participants after ensuring they fully understood the procedure and had the opportunity to ask questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Double scleral flap | Experimental | Procedure: Double scleral flapDouble 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. |
| Quadruple scleral flap | Experimental | Procedure: Quadruple scleral flapQuadruple 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Diagnosed with conditions necessitating evisceration with implant
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Previous ocular surgery affecting orbital anatomy
- Systemic conditions influencing wound healing (e.g., diabetes, autoimmune disorders)
- Allergy to implant materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadruple scleral flapQuadruple 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 or surgery | Quadruple scleral flap |
| Double scleral flapThe 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. | Procedure or surgery | Double scleral flap |
Primary outcome
Evaluating the post-operative extrusion rates of the ball implant from the scleral shell
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.
3 secondary outcomes
Postoperative pain
Time frame: From enrollment to the end of the follow up period after 6 months
Postoperative complications
Time frame: From enrollment to the end of the follow up period after 6 months
Patient satisfaction with implant motility
Time frame: From enrollment to the end of the follow up period after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadruple scleral flap and Double scleral flap in people with Evisceration; Traumatic, Eye, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the post-operative extrusion rates of the ball implant from the scleral shell (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.