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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06389643
Enrollment
50
Registered
2024-04-29
Start date
2021-03-19
Completion date
2023-09-19
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphakia

Keywords

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

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)

Detailed description

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.

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.

Sponsors

Military Institute od Medicine National Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
BCVAbefore and 12 months after surgeryThe change of best- corrected visual acuity
RE12 months after surgeryPostoperative total refractive error
ECCbefore and 12 months after surgerycorneal endothelial cell density

Secondary

MeasureTime frameDescription
Number of complicationsfrom day 1 until 12 months after surgeryRate of complications

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026