Lens SubluxationNCT06627062
A Modified-simple Technique for Managing Moderate and Severe Subluxated Lens Extraction
An observational study of Lens Subluxation, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lens Subluxation
- What is being tested?
- moderate and severe subluxated lens extraction
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 28 Feb 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with moderate to severe lens subluxation ranging from 120-300 degrees caused by different reasons.
Who cannot join
- Unable to cooperate in completing the lens subluxation surgery Lens subluxation accompanied by eyeball rupture injury Refuse surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Intrascleral Fixation of Standard Capsular Tension Ring： a Modified-simple Technique for Managing Moderate and Severe Subluxated Lens Extraction
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.
Read the 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 (\<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.
- Conditions
- Lens Subluxation
- Being tested
- moderate and severe subluxated lens extraction
- Keywords
- Subluxated lens, Capsular bag, capsular tension ring, phacoemulsification
- Medical subject headings
- Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate and severe subluxated lens extractionProcedure or surgery
Also called Intrascleral Fixation of Standard Capsular Tension Ring
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: moderate and severe subluxated lens extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of intraocular lens implantation in patients with moderate to severe subluxation of the crystalline lens
Measured: From enrollment to the end of treatment at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lens SubluxationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yinghong Ji, Phd; MD, Principal investigator, Eye & ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627062
- Sponsor's protocol ID
- 202119
- Status last verified
- Oct 2024
- First submitted
- 22 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41613822
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrascleral Fixation of Standard Capsular Tension Ring： a Modified-simple Technique for Managing Moderate and Severe Subluxated Lens Extraction
- ClinicalTrials.gov ID
- NCT06627062
- Acronym / sponsor ID
- 202119
- Conditions
- Lens Subluxation
- Keywords
- Subluxated lens, Capsular bag, capsular tension ring, phacoemulsification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 4 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 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 (\<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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subluxated lens extraction | – | Procedure: moderate and severe subluxated lens extractionThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with moderate to severe lens subluxation ranging from 120-300 degrees caused by different reasons.
Key exclusion criteria (1 listed)
- Unable to cooperate in completing the lens subluxation surgery Lens subluxation accompanied by eyeball rupture injury Refuse surgery
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 |
|---|---|---|
| moderate and severe subluxated lens extractionAlso: Intrascleral Fixation of Standard Capsular Tension RingA 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). | Procedure or surgery | subluxated lens extraction |
Primary outcome
Success rate of intraocular lens implantation in patients with moderate to severe subluxation of the crystalline lens
Time frame: From enrollment to the end of treatment at 1 year.
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 4 Oct 2024.
- Derived from this study: PubMed 41613822Ning 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.
- Individual participant dataSharing planned: No
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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.
Yinghong Ji, Phd; MD principal investigator
Eye & ENT Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lens Subluxation, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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 1 inclusion and 1 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 4 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 China. 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?
Success rate of intraocular lens implantation in patients with moderate to severe subluxation of the crystalline lens (time frame: From enrollment to the end of treatment at 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06627062, which also lists 1 linked publication.
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 4 Oct 2024.