Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636630
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Comparing Double VS Quadruple Flap for Securing Ball Implants After Eye Ball Evisceration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Efficacy of Double Flap Versus Quadruple Flap Techniques in Stabilizing Ball Implants Post-Evisceration a Comparative Analysis
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 of the closure techniques
5 Comparing patient satisfaction and quality of life measures
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 of the closure techniques
5 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None