Surgical Treatment of Marfan Syndrome With Subluxation Lens

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05578469
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 108
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Marfan Syndrome; Lens Subluxation or Dislocation	Procedure: surgical treatment of Marfan Syndrome with subluxation lens

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Effect of Different Surgical Treatment of Marfan Syndrome With Subluxation Lens
• Actual Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Uncorrected distance visual acuity [1 month postoperatively]

2. Uncorrected distance visual acuity [3 month postoperatively]

3. Corrected distance visual acuity [1 month postoperatively]

4. Corrected distance visual acuity [3 month postoperatively]

5. intraocular pressure [1 month postoperatively]

6. intraocular pressure [3 month postoperatively]

7. postoperative complication [Early and late stages]

Secondary Outcome Measures

1. Postoperative astigmatism and astigmatism axial of cornea [1 month postoperatively]

2. Postoperative astigmatism and astigmatism axial of cornea [3 month postoperatively]

3. endothelial cell count [1 month postoperatively]

4. endothelial cell count [3 month postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou		China

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05578469
• Other Study ID Numbers: 2022-0765
• First Posted: Oct 13, 2022
• Last Update Posted: Oct 13, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Joint Dislocations; Marfan Syndrome; Arachnodactyly; Lens Subluxation; Syndrome

Study Results

No Results Posted as of Oct 13, 2022