NCT05578469

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 13, 2022

Status Verified

September 1, 2022

Enrollment Period

6.8 years

First QC Date

October 11, 2022

Last Update Submit

October 11, 2022

Conditions

Marfan SyndromeLens Subluxation or Dislocation

Outcome Measures

Primary Outcomes (7)

  • Uncorrected distance visual acuity

    1 month postoperatively

  • Uncorrected distance visual acuity

    3 month postoperatively

  • Corrected distance visual acuity

    1 month postoperatively

  • Corrected distance visual acuity

    3 month postoperatively

  • intraocular pressure

    1 month postoperatively

  • intraocular pressure

    3 month postoperatively

  • postoperative complication

    Early and late stages

Secondary Outcomes (4)

  • Postoperative astigmatism and astigmatism axial of cornea

    1 month postoperatively

  • Postoperative astigmatism and astigmatism axial of cornea

    3 month postoperatively

  • endothelial cell count

    1 month postoperatively

  • endothelial cell count

    3 month postoperatively

Study Arms (2)

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

Interventions

surgical treatment of Marfan Syndrome with subluxation lensPROCEDURE

different surgical treatment of Marfan Syndrome with subluxation lens

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

Eligibility Criteria

Age8 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Conditions

Marfan SyndromeLens Subluxation

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornConnective Tissue DiseasesSkin and Connective Tissue DiseasesLens DiseasesEye Diseases

Study Design

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

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 13, 2022

Study Start

January 1, 2016

Primary Completion

November 1, 2022

Study Completion

December 30, 2024

Last Updated

October 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)