Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627062
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
A Modified-simple Technique for Managing Moderate and Severe Subluxated Lens Extraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intrascleral Fixation of Standard Capsular Tension Ring a Modified-simple Technique for Managing Moderate and Severe Subluxated Lens Extraction
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 investigators describe a modified knotless Z-suture technique to stabilize the capsular bag to the sclera in eyes with moderate and severe ectopic lentis requiring cataract surgery using a standard CTR This technology has the advantages of few complications low technical difficulty and no dependence on complex equipment
Detailed Description:
A dislocated crystalline lens also known as ectopia lentis is the result of lax zonule fibers causing the lens to dislocate from its anatomical position which can be caused by various factors such as inherited autosomal dominant disorders trauma or several systemic diseases According to the ratio of the pupil area uncovered by the lens to the whole pupil area after mydriasis the degree of subluxation of the crystalline lens can be divided into three grades mild 0-25 moderate 25-50 and severe more than 50 Moderate or severe cases may manifest as progressive blurred vision monodiplopia or even secondary angle-closure glaucoma resulting in a poor prognosis thereby emphasizing the urgency for effective therapeutic interventions Preserving the posterior capsular diaphragm is the key to preventing glaucoma optic capture and retinal detachment
Phacoemulsification and fixation of the capsular bag have been described with various methods and devices such as intraoperative use of iris hooks orcapsular retractors and permanent capsular support like Capsular tension rings CTRs firstly introduced in 1993 by Legler et al6 It is recommended to use a standard CTR when the zonular weakness is less than 120 degrees amplt4 clock hours However in instances of more extensive zonular weakness and progressive pathologies such as Marfan syndrome Weill-Marchesani syndrome pseudo exfoliation high myopia and homocystinuria intrascleral fixation of the capsular bag with a capsular tension segment CTS a modified CTR m-CTR or other devices such as the Assia Anchor is recommended6 However m-CTR and a variety of new capsule assist devices are difficult to obtain in some countries Therefore how to make the most of the common auxiliary tools such as standard CTR in moderate and severe subluxation to retain the capsular bag requires ophthalmologists to continue exploring
The investigators describe a novel technique of stabilizing a moderate or severe subluxated capsular bag which utilizes double-strand polypropylene sutures to suspend a standard capsular tension ring thereby enabling safe insertion of an intraocular lens IOL within the bag The technique has been successfully demonstrated in 16 eyes of nine patients with congenital or traumatic lens subluxations ranging between 120 and 300 degrees
Phacoemulsification and fixation of the capsular bag have been described with various methods and devices such as intraoperative use of iris hooks orcapsular retractors and permanent capsular support like Capsular tension rings CTRs firstly introduced in 1993 by Legler et al6 It is recommended to use a standard CTR when the zonular weakness is less than 120 degrees amplt4 clock hours However in instances of more extensive zonular weakness and progressive pathologies such as Marfan syndrome Weill-Marchesani syndrome pseudo exfoliation high myopia and homocystinuria intrascleral fixation of the capsular bag with a capsular tension segment CTS a modified CTR m-CTR or other devices such as the Assia Anchor is recommended6 However m-CTR and a variety of new capsule assist devices are difficult to obtain in some countries Therefore how to make the most of the common auxiliary tools such as standard CTR in moderate and severe subluxation to retain the capsular bag requires ophthalmologists to continue exploring
The investigators describe a novel technique of stabilizing a moderate or severe subluxated capsular bag which utilizes double-strand polypropylene sutures to suspend a standard capsular tension ring thereby enabling safe insertion of an intraocular lens IOL within the bag The technique has been successfully demonstrated in 16 eyes of nine patients with congenital or traumatic lens subluxations ranging between 120 and 300 degrees
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