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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilitary Institute od Medicine National Research Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

only adult men and women with subluxation lens

Disqualifiers

previous ocular surgery

Fuchs' dystrophy

corneal haze or scarring

history of corneal transplantation

Trial design

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Scleral fixation of the capsular bag-intraocular lens complex with permanent use of iris retractorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

BCVA

The change of best- corrected visual acuity

Time frame
before and 12 months after surgery
2

RE

Postoperative total refractive error

Time frame
12 months after surgery
3

Position IOL

Tilt and decentration IOL

Time frame
1 month and 12 months after surgery

Secondary outcomes

1

Number of complications

Rate of complications

Time frame
from day 1 until 12 months after surgery

Other outcomes

Sponsors and contacts

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