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

NCT ID: NCT07257172

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2026-01-31

Brief Summary

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

Detailed Description

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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

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Lens Subluxation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Institute od Medicine National Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ophthalmology Department, Military Institute of Medicine - National Research Institute

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Natalia Blagun, MD.

Role: CONTACT

+48533179497

Facility Contacts

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Natalia Blagun, MD

Role: primary

+48533179497

Other Identifiers

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12/WIM/2021

Identifier Type: -

Identifier Source: org_study_id

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