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The Scharioth Macular Lens

A Clinical Research Trial in Advanced Macular Disease

the 'Efficacy and Safety of the Scharioth Macular Lens in advanced AMD'

Frequently Asked Questions

What is the Scharioth Macular Lens?

The SML is a bifocal add-on intraocular lens which has been specifically designed with the intention of monocular implantation in the better-seeing eye to provide power without affecting distance vision or visual field. 

Who invented the SML?

The SML is a joint innovation of Professor Gábor Scharioth, MD, PhD, and 'Medicontur Medical Engineering', a medical device company who have over 30 years focused experience with intraocular implants and manufactured more than 4 million devices.

What are the benefits of the SML?

  • The SML gives the eye a more natural scanning technique.

 

  • The acuity is set for near viewing activities such a reading, but it should not disturb distance viewing.

  • It is cosmetically pleasing. 

  • The surgical procedure should be straight forward with a fast recovery timeframe.

  • It should be helpful to patients with a moderate loss of vision. 

  • The procedure can be reversed. 

  • As part of this research study, there is not any cost to participants. 

  • One of the advantages the SML has over other magnifiers is that it is a foldable lens. This means that only a small incision of 2 mm to 3 mm is required reducing the risk of complications. 

Does the lens get removed at the end of the research project?

No. The device remains in the eye and does not need to be replaced. 

For those in Group 2 - will the contact lens still be available the trial?

This will be dependent on how successful and beneficial the contact lens proves to be. 

If my 'dry' AMD becomes 'wet' after the implant, can it still be treated?

Yes, wet AMD can still be treated with the SML device in situ. It is beneficial in that it enables the medical team to have a good view of the retina when administering treatment. 

How would my private health insurance be affected?

Research trials do not normally affect private health care policies but confirmation should be made with them directly before participating.

What happens if I wish to withdraw from the study?

Participants may withdraw, or be withdrawn, from the trial at any time without prejudice. Their standard of care will not be affected.

Group 1

Participants

The trial will have two treatment groups. Eligible patients will either have the Scharioth Macular Lens implanted in the eye, or for those who have not had previous cataract surgery a contact lens magnifier will be provided.

'Group 1' will trial the contact lens before they undergo surgery which allows an opportunity to test the benefits beforehand. 

Afterwards, each participant will be tested for new glasses and provided with an up-to-date prescription. Numerous sessions will also be provided for the use of any supplementary low vision aids.

 

Participants who qualify for this group but opt-out may be eligible for 'Group 2'.

Schedule of appointments for participants in each group

Group 2

Participants

Participants in 'Group 2' will receive the contact lens magnifier to use for daily activities. 

They will be tested for new glasses and supplied with an up-do-date prescription. Training will be given at various training sessions to ensure any supplementary low vision aids are used to achieve their full potential. 

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