Lens SubluxationNCT07257172
Sutureless Technique for Repositioning and Scleral Fixation of the Capsular Bag - Intraocular Lens Complex With Permanent Use of Iris Retractors
A study testing Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors in people with Lens Subluxation, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
Sutureless technique for repositioning and scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lens Subluxation
- What is being tested?
- Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 28 May 2021to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- only adult men and women with subluxation lens
Who cannot join
- previous ocular surgery
- Fuchs' dystrophy
- corneal haze or scarring
- history of corneal transplantation
- clinically active uveitis
- advanced glaucoma
- macular diseases that affect visual acuity (age-related macular degeneration, diabetic maculopathy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Ophthalmology Department, Military Institute of Medicine - National Research Institute
Warsaw, Masovian Voivodeship, 04-141
Natalia Blagun, MD, +48533179497, nblagun@gmail.com
Natalia Blagun, MD
About this study
Sutureless technique for repositioning and scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors
Read the detailed description
Purpose of the study is to present results of sutureless technique for repositioning and scleral fixation of the capsular bag-intraocular lens (IOL) complex in the surgical treatment of subluxated lenses. The investigators rated the BCVA, refractive outcomes, intraocular pressure, , tilt and decentration, and also determined intra- and postoperative complications.
- Conditions
- Lens Subluxation
- Being tested
- Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors
- Keywords
- Lens Subluxation, iris retractors, sutureless fixation
- Medical subject headings
- Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractorsProcedure or surgery
The surgery was performed under retrobulbar anesthesia with 2% xylocaine and 0.5% bupivacaine. A 2.2 mm temporal clear-corneal incision and three side ports were created, followed by capsulorhexis with forceps. Due to limited vitreous prolapse, anterior vitrectomy was required. Iris retractors were inserted through the ports and positioned under the anterior capsule at the site of zonular loss. Phacoemulsification was completed with standard or reduced flow, a CTR was implanted, and a foldable one-piece IOL was placed in the bag. After removing the silicone stoppers, the retractors were lifted from the capsulotomy. A 25-gauge needle was passed 2 mm posterior to the limbus into the anterior chamber, aligned with zonular damage. The tip of one retractor was inserted into the needle and externalized; the ends were trimmed, cauterized, and the melted tip fixed subconjunctivally.
| Study group | Role | What they receive |
|---|---|---|
| Scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors | Experimental | Scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors Receives: Procedure: Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
The change of best- corrected visual acuity
Measured: before and 12 months after surgery
RE
Postoperative total refractive error
Measured: 12 months after surgery
Position IOL
Tilt and decentration IOL
Measured: 1 month and 12 months after surgery
Secondary outcomes (1)
Number of complications
Rate of complications
Measured: from day 1 until 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start28 May 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
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 Lens SubluxationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257172
- Sponsor's protocol ID
- 12/WIM/2021
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blagun N, Krix-Jachym K, Rekas M. Sutureless capsular bag-intraocular lens complex scleral fixation using iris retractors in eyes with crystalline lens subluxation: long-term outcome. Sci Rep. 2026 May 25;16(1):23786. doi: 10.1038/s41598-026-54569-y.
PubMed 42185526
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutureless Technique for Repositioning and Scleral Fixation of the Capsular Bag - Intraocular Lens Complex With Permanent Use of Iris Retractors
- ClinicalTrials.gov ID
- NCT07257172
- Acronym / sponsor ID
- 12/WIM/2021
- Conditions
- Lens Subluxation
- Keywords
- Lens Subluxation, iris retractors, sutureless fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 2 Dec 2025 (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.
Sutureless technique for repositioning and scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors
Detailed description
Purpose of the study is to present results of sutureless technique for repositioning and scleral fixation of the capsular bag-intraocular lens (IOL) complex in the surgical treatment of subluxated lenses. The investigators rated the BCVA, refractive outcomes, intraocular pressure, , tilt and decentration, and also determined intra- and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors | Experimental | Procedure: Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractorsScleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- only adult men and women with subluxation lens
Key exclusion criteria (7 listed)
- previous ocular surgery
- Fuchs' dystrophy
- corneal haze or scarring
- history of corneal transplantation
- clinically active uveitis
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 |
|---|---|---|
| Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractorsThe surgery was performed under retrobulbar anesthesia with 2% xylocaine and 0.5% bupivacaine. A 2.2 mm temporal clear-corneal incision and three side ports were created, followed by capsulorhexis with forceps. Due to limited vitreous prolapse, anterior vitrectomy was required. Iris retractors were inserted through the ports and positioned under the anterior capsule at the site of zonular loss. Phacoemulsification was completed with standard or reduced flow, a CTR was implanted, and a foldable one-piece IOL was placed in the bag. After removing the silicone stoppers, the retractors were lifted from the capsulotomy. A 25-gauge needle was passed 2 mm posterior to the limbus into the anterior chamber, aligned with zonular damage. The tip of one retractor was inserted into the needle and externalized; the ends were trimmed, cauterized, and the melted tip fixed subconjunctivally. | Procedure or surgery | Scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors |
Primary outcome
BCVA
Time frame: before and 12 months after surgery
The change of best- corrected visual acuity
RE
Time frame: 12 months after surgery
Postoperative total refractive error
Position IOL
Time frame: 1 month and 12 months after surgery
Tilt and decentration IOL
1 secondary outcome
Number of complications
Time frame: from day 1 until 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 42185526Blagun N, Krix-Jachym K, Rekas M. Sutureless capsular bag-intraocular lens complex scleral fixation using iris retractors in eyes with crystalline lens subluxation: long-term outcome. Sci Rep. 2026 May 25;16(1):23786. doi: 10.1038/s41598-026-54569-y.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors in people with Lens Subluxation, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 7 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Blagun, MD. (+48533179497, nblagun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: before and 12 months after surgery). The study lists 3 primary outcomes in all. 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 NCT07257172, 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 2 Dec 2025.