NCT06627062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

September 22, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

Subluxated lensCapsular bagcapsular tension ringphacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Success rate of intraocular lens implantation in patients with moderate to severe subluxation of the crystalline lens

    From enrollment to the end of treatment at 1 year.

Study Arms (1)

subluxated lens extraction

This research cohort consists of patients with moderate to severe subluxation who have successfully undergone lens extraction using an improved scleral fixation standard tension ring technique.

Procedure: moderate and severe subluxated lens extraction

Interventions

A double-strand polypropylene suture (9-0 or 8-0) was looped and tied to one end of the preloaded CTR, which was then implanted into the capsular bag. The needle was inserted through the main incision, traversed the anterior chamber, under the posterior iris, and exited 2.0 mm behind the limbus at the central zonular weakness. The CTR was secured to the sclera using the knotless Z-suture technique to center the capsular bag, allowing safe insertion of the intraocular lens (IOL).

Also known as: Intrascleral Fixation of Standard Capsular Tension Ring
subluxated lens extraction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

  • Ning L, Hong Y, Ji Y. Intrascleral fixation of standard capsular tension ring: a modified-simple technique for managing moderate and severe subluxated lens extraction. Ther Adv Ophthalmol. 2026 Jan 27;18:25158414251407874. doi: 10.1177/25158414251407874. eCollection 2026 Jan-Dec.

MeSH Terms

Conditions

Lens Subluxation

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Yinghong Ji, Phd; MD

    Eye & ENT Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2024

First Posted

October 4, 2024

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

February 28, 2024

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations