Surgical Treatment of Marfan Syndrome With Subluxation Lens

October 11, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China
        • Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with lens dislocation of Marfan syndrome who accepted different surgical treatments

Description

Inclusion Criteria:

  1. Patients diagnosed with MFS according to the revised Ghent etiology.
  2. refractive errors difficult to correct.
  3. pupillary block glaucoma caused by severe dislocation of the lens

Exclusion Criteria:

Keratoconus, late glaucoma, uveitis, history of traumatic lens dislocation, and preoperative retinal rupture with or without retinal detachment (RD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
posterior chamber intraocular lens(IOL) implantation with a Cionni capsular tension ring (CTR)
Procedure: surgical treatment of Marfan Syndrome with subluxation lens
different 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
different surgical treatment of Marfan Syndrome with subluxation lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Uncorrected distance visual acuity
Time Frame: 1 month postoperatively
1 month postoperatively
Uncorrected distance visual acuity
Time Frame: 3 month postoperatively
3 month postoperatively
Corrected distance visual acuity
Time Frame: 1 month postoperatively
1 month postoperatively
Corrected distance visual acuity
Time Frame: 3 month postoperatively
3 month postoperatively
intraocular pressure
Time Frame: 1 month postoperatively
1 month postoperatively
intraocular pressure
Time Frame: 3 month postoperatively
3 month postoperatively
postoperative complication
Time Frame: Early and late stages
Early and late stages

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative astigmatism and astigmatism axial of cornea
Time Frame: 1 month postoperatively
1 month postoperatively
Postoperative astigmatism and astigmatism axial of cornea
Time Frame: 3 month postoperatively
3 month postoperatively
endothelial cell count
Time Frame: 1 month postoperatively
1 month postoperatively
endothelial cell count
Time Frame: 3 month postoperatively
3 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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