Comparison of postoperative parameters in cataract surgery with two different fluidic settings

Plain English summary of protocol

Background and study aims
Cataracts are cloudy areas on the lens of the eye. They can appear for a number of reasons however they are most common in older people, developing over a long period of time (senile cataract). The lens sits near the front of the eye, and plays an important role in vision. When cataracts cause the lens to become clouded, it can prevent light from reaching the back of the eye (retina) to form an image that can be interpreted by the brain. When this happens, vision becomes blurred and distorted, and can eventually lead to blindness. Cataract surgery involves removing the affected lens and replacing it with a clear artificial one (intraocular lens). Modern cataract surgery is usually performed using a technique called phacoemulsification, also called small-incision surgery. This is where ultrasound waves (high-frequency sound waves) are used to break up the affected lens in the eye and mixed with a salt water solution (saline) that is injected into the eye by the phacoemulsification machine (emulsification), so it can be sucked (aspirated) out through a tiny cut in the cornea (transparent layer forming the front of the eye). The replacement lens is then injected through the cut in the cornea into the correct position. Many surgeons use different amounts of liquid for the emulsification. Some argue that using smaller amounts could help to prevent damage (trauma) to the eye than the standard amounts used, however further research is needed to find out whether this is the case. The aim of this study is to compare the amount of saline used with the overall effects on the eye following cataract surgery.

Who can participate?
Adults aged between 55 and 85 who have senile cataracts.

What does the study involve?
Participants are randomly allocated to one of two groups. All participants receive cataract surgery using the phacoemulsification technique to remove the affected lens before it is replaced by an artificial one. For those in group 1, the phacoemulsification machine is put on a low fluidic setting, which means a smaller amount of fluid is injected into the eye. For those in group 2, the phacoemulsification machine is put on a standard fluidic setting, which means that the normal amount of fluid is injected into the eye. For all participants, the length of surgery and the amount of fluid used is measured for each procedure. At the start of the study and then again after 1 day, 3 weeks and 3 months, all participants have an eye exam in order to see if the procedure used has had an effect on their eye health (whether any eye damage has been caused).

What are the possible benefits and risks of participating?
Participants benefit from taking part as they receive thorough eye examinations which they would not normally be given. There are no risks of taking part in the study other than the general risks associated with cataract surgery.

Where is the study run from?
St. Erik Eye Hospital (Sweden)

When is the study starting and how long is it expected to run for?
October 2011 to April 2015

Who is funding the study?
1. Karolinska Institute (Sweden)
2. Stockholm County Council (Sweden)

Who is the main contact?
Dr Anthony Chang

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Sweden

Study participating centre

Sponsor information

Funders

Funder type

Government

Results and Publications