Rigid iris-fixated phakic lens implantation for high myopia: Novel trapezoidal corneal versus scleral incisions

Comparison of refractive performance of implantation of an iris-fixated phakic intraocular lens (PIOL) through a novel trapezoidal corneal and a scleral tunnel incision.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000914066

Enrollment

Registered

2010-10-26

Start date

2006-06-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Implantation of rigid iris-fixated phakic intraocular lens (PIOL) is considered as a promising alternative for high myopia. However, a conventional large sclerocorneal or scleral incision is commonly needed for this PIOL implantation because of the polymethylmethacrylate material. Thus, it involves much ocular tissue manipulation and surgical time, which should induce the postoperative astigmatisms and affect the rapid postoperative visual recovery. Although the foldable version of lens has been created recently, it is a rather new technique and long-term evaluation is not available. Therefore, the rigid PIOL is still a widely accepted and frequently used means for high myopia, especially in developing countries. Therefore, we present a novel surgical technique that is specially designed for rigid PIOL implantation and compare it with conventional scleral incision. This study aimed to compare the postoperative visual outcomes of these two incisions for the surgical correction of high myopia.

Interventions

Phakic iris-fixated intraocular lens implantation for high myopia through a novel self-sealing corneal incision. The procedure can be finished in 5-10min and performed once only each subject.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

(1) anterior chamber depth (ACD) of 3.0 mm or greater with regular iris configuration; (2) preoperative endothelial cell count of 2000 cells/mm2 or greater; (3) preoperative spherical equivalent (SE) greater than -15.0 D, with astigmatism less than 2.0 D; (4) stable refraction, defined as less than 0.5 D change for more than 1 year; (5) no other ocular and systemic diseases.

Exclusion criteria

(1) abnormal iris, cornea, pupil, or retina; (2) acute inflammation; (3) any form of cataract; (4) glaucoma; (5) chronic or recurrent uveitis; (6) preexisting macular degeneration, retinopathy, or family history of retinal detachment; (7) intraocular pressure (IOP) higher than 21mm Hg; (8) chronic treatment with corticosteroids or any immunosuppressive treatment or state.

Outcome results