## Protocol Section
### Identification Module
**NCT ID:** NCT06423079

**Brief Title:** Scleral Fixation for Intraocular Lens-Bag Dislocation

**Official Title:** Complex Intaocular Lens-Bag Fixation With Siepser's Scleral Sliding Knots

#### Organization Study ID Info
**ID:** Siep_001
#### Organization
**Class:** OTHER
**Full Name:** University of Naples
### Status Module
#### Completion Date
**Date:** 2022-05-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-05-10

**Type:** ACTUAL

#### Start Date
**Date:** 2017-05-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Naples

#### Responsible Party

**Investigator Affiliation:** University of Naples

**Investigator Full Name:** Luca D'Andrea

**Investigator Title:** Prinicipal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**Detailed Description:** 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 Module

**Conditions:**

- Pseudoexfoliation Syndrome

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 36

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Siepser knots

**Label:** IOL-Bag Dislocation patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IOL-Bag Dislocation patients

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

**Name:** Siepser knots

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** to evaluate the best corrected visual acuity after the surgery

**Measure:** Best corrected visual acuity

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** to evaluate the Endothelial cells count after the surgery

**Measure:** Endothelial cells count

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex after cataract surgery.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** NAples

**Country:** Italy

**Facility:** University of Naples Federico II

**Zip:** 80131

### IPD Sharing Statement Module

**Access Criteria:** available on request

**Description:** all collected IPD

**IPD Sharing:** YES

**Time Frame:** 5 years

**URL:** https://guides.lib.umich.edu/datamanagement/clinicaltrials

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007499

- Term: Iris Diseases

- ID: D000014603

- Term: Uveal Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20069

- Name: Exfoliation Syndrome

- Relevance: HIGH

- As Found: Pseudoexfoliation Syndrome

- ID: M7385

- Name: Joint Dislocations

- Relevance: LOW

- As Found: Unknown

- ID: M10531

- Name: Iris Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17351

- Name: Uveal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5824

- Name: Uveal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017889

- Term: Exfoliation Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
