Dry Eye Clinical Trial
Official title:
Clinical Effects of Diquas-S for Patients With Dry Eye After Cataract Surgery
Today, cataract surgery has become one of the safest and most effective eye surgical
procedures performed on many people through the development and development of surgical
techniques and instruments. However, a significant number of patients who underwent cataract
surgery still complain about postoperative symptoms, such as irritation, pain, dryness,
burning sensation, and foreign body sensation. The reasons of dry eye (DE) development after
cataract surgery include thermal and light toxicity from the microscope, corneal epithelial
damage, and frequent irrigation of ocular surface during operation, sterilization of
conjunctival sac and eyelid with chemicals, transection of the corneal nerves by corneal
incision, use of topical anesthetics, and preservatives in topical eye drops. In this era of
high expectation of patients and premium intraocular lenses, the postoperative discomforts
cannot be accepted to many patients. Several studies have recently reported that the common
cause of postoperative symptoms of the patients is DE. Furthermore, if the ocular surface is
deformed due to DE syndrome after surgery, the optical quality is greatly affected which
results in a decrease of the quality of vision. If the tear film becomes irregular, the
higher-order aberration can change due to local irregular total radius of curvature of ocular
surface and result in decreased visual acuity.
There have been many attempts to treat DE syndrome after cataract surgery. Artificial tears
are commonly used for the first line treatment of postoperative DE and several studies
revealed its effectiveness on management of DE symptoms and signs. The postoperative use of
cyclosporine 0.05 % topical eye drop improved DE symptoms and visual quality after cataract
surgery. Recently, diquafosol sodium ophthalmic solution has been used for the management of
DE after cataract. Diquafosol is a dinucleotide derivative and functions as agonist to the
purinergic P2Y2 receptor. Diquafosol is known to stimulate not only the mucin secretion from
the goblet cells but also water secretion from conjunctival epithelial cells and accessory
lacrimal glands. According to previous studies, diquafosol has been found to be very
effective in treating DE after cataract and to alleviate symptoms of DE syndrome.
Furthermore, several studies have shown that topical diquafosol has a better efficacy in
managing DE after cataract surgery than artificial tears. The preservative free diquafosol
ophthalmic solution has been released recently. The use of eye drops without preservatives
has also been shown to play an important role in the treatment of DE after cataract surgery.
Until now, there is no study that evaluated the effect of preservative free diquafosol
ophthalmic solution. Thus the investigators try to investigate the efficacy of preservative
free diquafosol ophthalmic solution compared to preservative containing diquafosol ophthalmic
solution and sodium hyaluronate ophthalmic solution, which are widely used in patients with
DE after cataract surgery.
Enrollment period : 24 months after IRB approval Participants : The subjects over 20 years
old, who visited Severance hospital for cataract surgery and has dry eye. The participants
who satisfies criteria, and who can be monitored at all times during each period of
observation after surgery are included in the study.
Methods: The subjects are randomly divided into three groups. Group 1 will use preservative
diquafosol ophthalmic solution, Group 2 will use preservative containing diquafosol
ophthalmic solution, and Group 3 will use preservative free sodium hyaluronate after cataract
surgery. Before surgery, all patients underwent a detailed ophthalmological examination that
included evaluation of logarithm of the minimum angle of resolution (logMAR)
uncorrected-distance visual acuity (UDVA) and CDVA, manifest refraction, slit-lamp
examination (Haag-Streit, Köniz, Switzerland), and dry eye parameters including tear breakup
time, schirmer test, OSDI, and MGD staging. All examinations were repeated at 1, and 3 months
after surgery.
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