ClinicalTrials.gg
RecruitingNCT07257172Updated Dec 2, 2025

Sutureless Technique for Repositioning and Scleral Fixation of the Capsular Bag - Intraocular Lens Complex With Permanent Use of Iris Retractors

An interventional study of Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors in Lens Subluxation, sponsored by Military Institute od Medicine National Research Institute. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Military Institute od Medicine National Research Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Registered 4 years 5 months after the study started (first participant enrolled May 2021, registered Nov 2025).
  • Started May 2021; still recruiting 5 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lens Subluxation

Keywords

  • Lens Subluxation
  • iris retractors
  • sutureless fixation
03

In context

Lead sponsor

Military Institute od Medicine National Research Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • only adult men and women with subluxation lens

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors

    Scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors

    Procedure: Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors

Interventions

  • ProcedureSutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors

    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.

06

What researchers measure

Primary outcomes

  1. BCVA

    The change of best- corrected visual acuity

    Time frame: before and 12 months after surgery

  2. RE

    Postoperative total refractive error

    Time frame: 12 months after surgery

  3. Position IOL

    Tilt and decentration IOL

    Time frame: 1 month and 12 months after surgery

Secondary outcomes

  1. Number of complications

    Rate of complications

    Time frame: from day 1 until 12 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Ophthalmology Department, Military Institute of Medicine - National Research Institute
    Warsaw, Masovian Voivodeship 04-141, Poland
    Recruiting
    • Natalia Blagun, MD · Contactnblagun@gmail.com · +48533179497
    • Natalia Blagun, MD · Principal investigator
    • Karolina Krix-Jachym, MD. PhD. · Principal investigator
    • Marek Rekas, Prof. PhD. MD. · Principal investigator
08

References and documents

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. doi: 10.1038/s41598-026-54569-y. Online ahead of print. PubMed 42185526 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07257172
Lead sponsor
Military Institute od Medicine National Research Institute
Responsible party
Sponsor
First posted
Dec 2, 2025
Start date
May 28, 2021
Primary completion
Jan 2026 (estimated)
Completion
Jan 2026 (estimated)
Last update
Dec 2, 2025

Study contacts

Natalia Blagun, MD.
Contact
nblagun@gmail.com
+48533179497

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion