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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07257172
Enrollment
40
Registered
2025-12-02
Start date
2021-05-28
Completion date
2026-01-31
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lens Subluxation

Keywords

Lens Subluxation, iris retractors, sutureless fixation

Brief summary

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

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.

Sponsors

Military Institute od Medicine National Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
BCVAbefore and 12 months after surgeryThe change of best- corrected visual acuity
RE12 months after surgeryPostoperative total refractive error
Position IOL1 month and 12 months after surgeryTilt and decentration IOL

Secondary

MeasureTime frameDescription
Number of complicationsfrom day 1 until 12 months after surgeryRate of complications

Countries

Poland

Contacts

Primary ContactNatalia Blagun, MD.
nblagun@gmail.com+48533179497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026