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

Browse trials for

• Aphakia 69

Keywords

• scleral fixation IOL
• sutureless fixation IOL
• four-point scleral fixation
• Yamane technique
• aphakia

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's enrollment of 50 is below the median of 103 across 52 interventional studies indexed under Aphakia.

Lead sponsor

Military Institute od Medicine National Research Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Study arms

• Active comparator
  Four-point scleral fixation group

  Four-point scleral fixation group

  Procedure: Four-point scleral fixation of Akreos AO60 IOL

• Active comparator
  Yamane technique group

  Yamane technique group

  Procedure: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique

Interventions

• ProcedureFour-point scleral fixation of Akreos AO60 IOL

  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.

• ProcedureSutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique

  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

   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. ECC

   corneal endothelial cell density

   Time frame: before and 12 months after surgery

Secondary outcomes

1. Number of complications

   Rate of complications

   Time frame: from day 1 until 12 months after surgery

Individual participant data

Plan to share: No