Menu
Recruiting NCT07257172

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

No phase Interventional Lens Subluxation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sutureless technique for repositioning and scleral fixation of the capsular bag - intraocular lens complex with permanent use of iris retractors.
Who it may be relevant to
Registry conditions: Lens Subluxation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Sutureless 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 o

Primary outcome measures

  • BCVA [Time frame: before and 12 months after surgery]
  • RE [Time frame: 12 months after surgery]
  • Position IOL [Time frame: 1 month and 12 months after surgery]
Secondary outcome measures (1)
  • Number of complications [Time frame: from day 1 until 12 months after surgery]

Eligibility criteria

Inclusion criteria

  • only adult men and women with subluxation lens

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Ophthalmology Department, Military Institute of Medicine - National Research Institute — Warsaw

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. PMID 42185526

Identifiers

NCT: NCT07257172 · 12/WIM/2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗