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

NCT07257172 | Recruiting

• 1 other identifier: 12/WIM/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lens Subluxation

Keywords

Lens Subluxation; iris retractors; sutureless fixation

Outcome Measures

Primary Outcomes (3)

• BCVA

  The change of best- corrected visual acuity

  before and 12 months after surgery

• RE

  Postoperative total refractive error

  12 months after surgery

• Position IOL

  Tilt and decentration IOL

  1 month and 12 months after surgery

Secondary Outcomes (1)

• Number of complications

  from day 1 until 12 months after surgery

Study Arms (1)

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

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• only adult men and women with subluxation lens

You may not qualify if:

• 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)

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Ophthalmology Department, Military Institute of Medicine - National Research Institute

Warsaw, Masovian Voivodeship, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Lens Subluxation

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Natalia Blagun, MD.

CONTACT

+48533179497; nblagun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: May 28, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)