Clinical trial NCT06627062: A Modified-simple Technique for Managing Moderate and Severe Subluxated Lens Extraction
Official title: Intrascleral Fixation of Standard Capsular Tension Ring： a Modified-simple Technique for Managing Moderate and Severe Subluxated Lens Extraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lens Subluxation
Keywords: Subluxated lens
Capsular bag
capsular tension ring
phacoemulsification
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The technique was successfully used in 16 eyes of 9 patients (including 3 females and 6males) with 15 congenital and 1 traumatic lens subluxations with subluxation ranges between 120-300 degrees.

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 (\&amp;lt;4 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.

Eligibility criteria: Inclusion Criteria:

- Patients with moderate to severe lens subluxation ranging from 120-300 degrees caused by different reasons.

Exclusion Criteria:

- Unable to cooperate in completing the lens subluxation surgery Lens subluxation accompanied by eyeball rupture injury Refuse surgery

Primary outcomes:
measure: Success rate of intraocular lens implantation in patients with moderate to severe subluxation of the crystalline lens
timeFrame: From enrollment to the end of treatment at 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye Institute and Department of Ophthalmology, Eye &amp; ENT Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital, Fudan University
name: Yinghong Ji, Phd; MD
role: PRINCIPAL_INVESTIGATOR
References: