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

Aphakia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06389643
• Other study ID #: 11/WIM/2021
• Status: Completed
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: September 19, 2023

Study information

• Verified date: April 2024
• Source: Military Institute od Medicine National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 19, 2023
• Est. primary completion date: September 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aphakia

Intervention

Procedure:
• Four-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.
• Sutureless 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.

Locations

Country	Name	City	State
Poland	Military Institute of Medicine - National Research Institute	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute od Medicine National Research Institute

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA	The change of best- corrected visual acuity	before and 12 months after surgery
Primary	RE	Postoperative total refractive error	12 months after surgery
Primary	ECC	corneal endothelial cell density	before and 12 months after surgery
Secondary	Number of complications	Rate of complications	from day 1 until 12 months after surgery