Hydrodissection sleeve to aid cataract surgery
Research type
Research Study
Full title
Hydrodissection sleeve to aid cataract surgery
IRAS ID
324911
Contact name
Anant Sharma
Contact email
Sponsor organisation
Medicel AG
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Cataract surgery is a common operation, with approximately 25 million procedures performed yearly worldwide. An essential step in the surgery is hydrodissection, in which fluid is forced into the eye through a cannula (thin tube) to free the cataract from its capsule so it can be removed. A serious and potentially sight threatening complication of this is iris prolapse, where the iris comes out of the wound made for instruments to be inserted through. This is possible because the hydrodissection cannula is smaller than the wound it is inserted through.
People at highest risk of iris prolapse include those who take a medication called Tamsulosin, as well as having a small pupil diameter, as their iris is floppier. These individuals have an 11.9% risk of it occurring, compared to the 0.9% risk in the general population having cataract surgery.
Traditional methods in managing iris prolapse have varying effects and success rates, and many have their own complications. This study aims to investigate how a new purpose-made sleeve can be used during hydrodissection to seal the wound so the iris cannot prolapse through it. The hydrodissection catheter can either be inserted through this sleeve, or through a smaller side port/secondary wound. Currently, this method is already employed using a sleeve designed for a different step in the surgery, but this study introduces a purpose-made, tapered sleeve to be used in the same fashion.
The population studied will be those at high risk as described above, as well as those with imminent iris prolapse identified during cataract surgery. Outcomes will be measured by number of cases of iris prolapse, with an aim for no iris prolapse through the main wound for the device to be labelled as successful.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0162
Date of REC Opinion
20 Feb 2024
REC opinion
Further Information Favourable Opinion