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

NCT06389643 | Completed

• 1 other identifier: 11/WIM/2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Aphakia

Keywords

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

Outcome Measures

Primary Outcomes (3)

• BCVA

  The change of best- corrected visual acuity

  before and 12 months after surgery

• RE

  Postoperative total refractive error

  12 months after surgery

• ECC

  corneal endothelial cell density

  before and 12 months after surgery

Secondary Outcomes (1)

• Number of complications

  from day 1 until 12 months after surgery

Study Arms (2)

Four-point scleral fixation group

ACTIVE COMPARATOR

Four-point scleral fixation group

Procedure: Four-point scleral fixation of Akreos AO60 IOL

Yamane technique group

ACTIVE COMPARATOR

Yamane technique group

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

Interventions

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.

Four-point scleral fixation group

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.

Yamane technique group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• only adult men and women with aphakia without capsular support

You may not qualify if:

• 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)

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine - National Research Institute

Warsaw, 04-141, Poland

Location

Related Publications (1)

• Blagun N, Krix-Jachym K, Rekas M. Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and the Yamane Technique. Ophthalmol Ther. 2024 Jul;13(7):1955-1966. doi: 10.1007/s40123-024-00962-7. Epub 2024 May 21.

  PMID: 38771460 DERIVED

MeSH Terms

Conditions

Aphakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Natalia Blagun, MD

  Military Institute of Medicine National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 29, 2024
• Study Start: March 19, 2021
• Primary Completion: September 14, 2022
• Study Completion: September 19, 2023
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)