NCT Number: NCT07257172
Sutureless technique for repositioning and scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractors
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Warsaw, Masovian Voivodeship, 04-141, Poland
Location status: Recruiting
Karolina Krix-Jachym, MD. PhD.
PRINCIPAL_INVESTIGATOR
Marek Rekas, Prof. PhD. MD.
PRINCIPAL_INVESTIGATOR
Natalia Blagun, MD
CONTACT
Natalia Blagun, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: before and 12 months after surgery
The change of best- corrected visual acuity
Time frame: 12 months after surgery
Postoperative total refractive error
Time frame: 1 month and 12 months after surgery
Tilt and decentration IOL
Time frame: from day 1 until 12 months after surgery
Rate of complications
Contact information is provided by the study sponsor or research team.
Military Institute od Medicine National Research Institute
Other
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