Scleral Fixation for Intraocular Lens-Bag Dislocation
Complex Intaocular Lens-Bag Fixation With Siepser's Scleral Sliding Knots
1 other identifier
observational
36
1 country
1
Brief Summary
Novel introflective sutures offer a minimally invasive approach for stable fixation of dislocated bag-IOL complexes, preserving visual acuity and reducing corneal complications in patients with pseudoexfoliation syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Longer than P75 for all trials
1 active site
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
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2022
CompletedFirst Submitted
Initial submission to the registry
May 15, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedMay 21, 2024
May 1, 2024
2 years
May 15, 2024
May 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Best corrected visual acuity
to evaluate the best corrected visual acuity after the surgery
1 year
Secondary Outcomes (1)
Endothelial cells count
1 year
Study Arms (1)
IOL-Bag Dislocation patients
Patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex.
Interventions
Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation
Eligibility Criteria
patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex after cataract surgery.
You may qualify if:
- patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex
You may not qualify if:
- patients who underwent intraoperative complications,
- dislocation in the vitreous chamber of the bag-IOL complex,
- patients who had already undergone posterior capsule Nd-YAG laser
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Naples Federico II
Naples, 80131, Italy
Related Publications (1)
Furgiuele D, Giunta P, Rinaldi M, D'Andrea L, Costagliola C. Innovative approach to IOL-bag complex fixation with Siepser's scleral sliding knots in pseudoexfoliation syndrome. Sci Rep. 2025 Aug 5;15(1):28522. doi: 10.1038/s41598-025-10542-9.
PMID: 40764517DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal investigator
Study Record Dates
First Submitted
May 15, 2024
First Posted
May 21, 2024
Study Start
May 10, 2017
Primary Completion
May 10, 2019
Study Completion
May 10, 2022
Last Updated
May 21, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 5 years
- Access Criteria
- available on request
all collected IPD