Pseudoexfoliation SyndromeNCT06423079
Scleral Fixation for Intraocular Lens-Bag Dislocation
An observational study of Pseudoexfoliation Syndrome, run by University of Naples at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pseudoexfoliation Syndrome
- What is being tested?
- Siepser knots
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2017to 10 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex after cataract surgery.
Who may be able to join
- patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complex Intaocular Lens-Bag Fixation With Siepser's Scleral Sliding Knots
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.
Read the 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
- Pseudoexfoliation Syndrome
- Being tested
- Siepser knots
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siepser knotsProcedure or surgery
Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation
| Study group | Role | What they receive |
|---|---|---|
| IOL-Bag Dislocation patients | Patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex. Receives: Procedure: Siepser knots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
to evaluate the best corrected visual acuity after the surgery
Measured: 1 year
Secondary outcomes (1)
Endothelial cells count
to evaluate the Endothelial cells count after the surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start10 May 2017
- Primary completion10 May 2019
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pseudoexfoliation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca D'Andrea, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423079
- Sponsor's protocol ID
- Siep_001
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 40764517
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Intaocular Lens-Bag Fixation With Siepser's Scleral Sliding Knots
- ClinicalTrials.gov ID
- NCT06423079
- Acronym / sponsor ID
- Siep_001
- Conditions
- Pseudoexfoliation Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOL-Bag Dislocation patients | – | Procedure: Siepser knotsPatients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex after cataract surgery.
Key inclusion criteria (1 listed)
- patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siepser knotsSurgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation | Procedure or surgery | IOL-Bag Dislocation patients |
Primary outcome
Best corrected visual acuity
Time frame: 1 year
to evaluate the best corrected visual acuity after the surgery
1 secondary outcome
Endothelial cells count
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 40764517Furgiuele 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.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoexfoliation Syndrome, run by University of Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06423079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.