Marfan SyndromeNCT05578469
Surgical Treatment of Marfan Syndrome With Subluxation Lens
An observational study of Marfan Syndrome and Lens Subluxation or Dislocation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To analyze the postoperative visual effects, and to compare the safety and efficacy of different surgical treatment with of Marfan Syndrome with subluxation lens. Read more about this study
- Who is it for?
- Ages 8 to 55 years
- Conditions the study is for
- Marfan Syndrome, Lens Subluxation or Dislocation
- What is being tested?
- surgical treatment of Marfan Syndrome with subluxation lens
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Dec 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 8 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with lens dislocation of Marfan syndrome who accepted different surgical treatments
Who may be able to join
- Patients diagnosed with MFS according to the revised Ghent etiology.
- refractive errors difficult to correct.
- pupillary block glaucoma caused by severe dislocation of the lens
Who cannot join
- Keratoconus, late glaucoma, uveitis, history of traumatic lens dislocation, and preoperative retinal rupture with or without retinal detachment (RD)
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
About this study
Official title: Effect of Different Surgical Treatment of Marfan Syndrome With Subluxation Lens
To analyze the postoperative visual effects, and to compare the safety and efficacy of different surgical treatment with of Marfan Syndrome with subluxation lens.
- Conditions
- Marfan Syndrome, Lens Subluxation or Dislocation
- Being tested
- surgical treatment of Marfan Syndrome with subluxation lens
- Medical subject headings
- Marfan Syndrome, Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatment of Marfan Syndrome with subluxation lensProcedure or surgery
different surgical treatment of Marfan Syndrome with subluxation lens
| Study group | Role | What they receive |
|---|---|---|
| posterior chamber intraocular lens(IOL) implantation with a Cionni capsular tension ring (CTR) | Not described Receives: Procedure: surgical treatment of Marfan Syndrome with subluxation lens | |
| sutured scleral fixation of posterior chamber IOL/ posterior chamber IOL and CTR | Not described Receives: Procedure: surgical treatment of Marfan Syndrome with subluxation lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distance visual acuity
Measured: 1 month postoperatively
Uncorrected distance visual acuity
Measured: 3 month postoperatively
Corrected distance visual acuity
Measured: 1 month postoperatively
Corrected distance visual acuity
Measured: 3 month postoperatively
intraocular pressure
Measured: 1 month postoperatively
intraocular pressure
Measured: 3 month postoperatively
postoperative complication
Measured: Early and late stages
Secondary outcomes (4)
Postoperative astigmatism and astigmatism axial of cornea
Measured: 1 month postoperatively
Postoperative astigmatism and astigmatism axial of cornea
Measured: 3 month postoperatively
endothelial cell count
Measured: 1 month postoperatively
endothelial cell count
Measured: 3 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jan 2016
- Primary completion1 Nov 2022 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marfan SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578469
- Sponsor's protocol ID
- 2022-0765
- Status last verified
- Sep 2022
- First submitted
- 11 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Surgical Treatment of Marfan Syndrome With Subluxation Lens
- ClinicalTrials.gov ID
- NCT05578469
- Acronym / sponsor ID
- 2022-0765
- Conditions
- Marfan Syndrome, Lens Subluxation or Dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
To analyze the postoperative visual effects, and to compare the safety and efficacy of different surgical treatment with of Marfan Syndrome with subluxation lens.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterior chamber intraocular lens(IOL) implantation with a Cionni capsular tension ring (CTR) | – | Procedure: surgical treatment of Marfan Syndrome with subluxation lens |
| sutured scleral fixation of posterior chamber IOL/ posterior chamber IOL and CTR | – | Procedure: surgical treatment of Marfan Syndrome with subluxation lens |
Who may qualify
- Ages
- 8 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with lens dislocation of Marfan syndrome who accepted different surgical treatments
Key inclusion criteria (3 listed)
- Patients diagnosed with MFS according to the revised Ghent etiology.
- refractive errors difficult to correct.
- pupillary block glaucoma caused by severe dislocation of the lens
Key exclusion criteria (1 listed)
- Keratoconus, late glaucoma, uveitis, history of traumatic lens dislocation, and preoperative retinal rupture with or without retinal detachment (RD)
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 |
|---|---|---|
| surgical treatment of Marfan Syndrome with subluxation lensdifferent surgical treatment of Marfan Syndrome with subluxation lens | Procedure or surgery | posterior chamber intraocular lens(IOL) implantation with a Cionni capsular tension ring (CTR), sutured scleral fixation of posterior chamber IOL/ posterior chamber IOL and CTR |
Primary outcome
Uncorrected distance visual acuity
Time frame: 1 month postoperatively
Uncorrected distance visual acuity
Time frame: 3 month postoperatively
Corrected distance visual acuity
Time frame: 1 month postoperatively
Corrected distance visual acuity
Time frame: 3 month postoperatively
intraocular pressure
Time frame: 1 month postoperatively
intraocular pressure
Time frame: 3 month postoperatively
postoperative complication
Time frame: Early and late stages
4 secondary outcomes
Postoperative astigmatism and astigmatism axial of cornea
Time frame: 1 month postoperatively
Postoperative astigmatism and astigmatism axial of cornea
Time frame: 3 month postoperatively
endothelial cell count
Time frame: 1 month postoperatively
endothelial cell count
Time frame: 3 month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Marfan Syndrome and Lens Subluxation or Dislocation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. 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?
Results are not available in the source record.
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?
Uncorrected distance visual acuity (time frame: 1 month postoperatively). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.