Scleral Fixation for Intraocular Lens-Bag Dislocation

NCT ID: NCT06423079

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-10

Study Completion Date

2022-05-10

Brief Summary

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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.

Detailed Description

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To assess the one-month outcomes of visual performance and positional stability of capsule-fixated intraocular lenses (IOLs) in patients with IOL-Bag complex dislocation. Patients with intraoperative complications or prior posterior capsule Nd-YAG laser were excluded. Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation. Best Corrected Visual acuity (BCVA), endothelial cell counts, and tonometry were assessed at multiple postoperative time points. We also evaluated the mean spherical equivalent (SE), and the residual cylinder and sphere at each follow-up.

Conditions

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Pseudoexfoliation Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IOL-Bag Dislocation patients

Patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex.

Siepser knots

Intervention Type PROCEDURE

Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation

Interventions

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Siepser knots

Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Naples

OTHER

Sponsor Role lead

Responsible Party

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Luca D'Andrea

Prinicipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples Federico II

Naples, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 40764517 (View on PubMed)

Other Identifiers

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Siep_001

Identifier Type: -

Identifier Source: org_study_id

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