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Completed

NCT Number: NCT06389643

Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques

Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Institute of Medicine - National Research Institute

Warsaw, 04-141, Poland

About this study

Purpose of the study is to compare two methods of scleral fixation of IOL: two-point fixation of AcrySof MA60AC IOL (Alcon) using Yamane technique and four-point fixation of the Akreos AO60 IOL (Bausch & Lomb) using polypropylene suture. The investigators rated the BCVA, refractive outcomes, intraocular pressure, and also determined intra- and postoperative complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • only adult men and women with aphakia without capsular support

Exclusion criteria

  • Fuchs' dystrophy
  • corneal haze or scarring
  • history of corneal transplantation
  • astigmatism of more than 2,0D
  • clinically active uveitis
  • advanced glaucoma
  • macular diseases that affect visual acuity (age-related macular degeneration, diabetic maculopathy)

Treatment and study plan

Four-point scleral fixation of Akreos AO60 IOL

Procedure

Intrascleral tunnels were marked at a distance of 2 mm from the corneal limbus, 6 mm apart (4 in number) after retrobulbar anesthesia. Next corneal incisions were performed. An artificial lens was then implanted into the anterior chamber. The 6-0 polypropylene suture was introduced into the anterior chamber through openings in the cornea. The next stage was to perform a sclerotomy using a 30G needle. Then the needle was passed through the hole in the haptic and 6-0 polypropylene suture was inserted into the needle hole and guided outside. The other end of the suture, passed through the opening in the haptic, was placed in the lumen of the needle and carried out through another sclerotomy and then externalised. This maneuver was repeated with another haptics as well. Correct position of the IOL in the eye was achieved by pulling on the ends of the monofilament. The ends of sutures were trimmed and cauterized. The melted tips of the sutures were then fixed subconjunctivally.

Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique

Procedure

The surgery was performed under retrobulbar anesthesia. The first step of the procedure was to mark the locations of the intrascleral tunnels (2 mm from the corneal limbus) and locate them at a distance of 180° from each other to prevent the lens from tilting in the eyeball. Openings in the cornea were done. Three-piece IOL was implanted into the anterior chamber. The first sclerotomy was performed through the conjunctiva using a 30G needle 2 mm from the limbus. One of the haptics was inserted into the needle lumen and then brought out. Same procedure was performed with another haptic at a distance of 180°. The next step was to perform cautery of the tips of the haptics, obtaining a 0.3 mm collar that prevents the risk of the haptic coming out of the tunnel and displacing the lens inside the eyeball. The tips of the haptics were finally gently inserted into the scleral canals and covered with conjunctiva.

Primary outcomes

  1. BCVA

    Time frame: before and 12 months after surgery

    The change of best- corrected visual acuity

  2. RE

    Time frame: 12 months after surgery

    Postoperative total refractive error

  3. ECC

    Time frame: before and 12 months after surgery

    corneal endothelial cell density

Secondary outcomes

  1. Number of complications

    Time frame: from day 1 until 12 months after surgery

    Rate of complications

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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