Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery
Condition: Dry Eye Syndromes
MeSH terms: Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Capsule Opacification
Study type: Interventional

Summary: 
      The purpose of this study is determine whether 3% diquafosol and 0.1% sodium hyaluronate are
      effective and safe in the treatment of patients with dry eye after cataract surgery.
    

Detailed description: 
      Study group and protocol: This was a prospective open-label randomized study. All patients
      were given a full explanation of the study, and written informed consent was obtained from
      all participants. The study protocol adhered to the tenets of the Declaration of Helsinki.
      The Institutional Review Board and Ethics Committee, Soonchunhyang University Seoul Hospital,
      approved this study (SCHUH 2013-12-012). Patients were randomly allocated into the diquafosol
      group (D group) or the hyaluronate group (H group) using a simple unrestricted randomization
      method by the controller. The D group used 3% diquafosol tetrasodium ophthalmic solution
      (Diquas®; Santen Pharmaceutical Co., Ltd., Osaka, Japan) six times a day and the H group used
      0.1% sodium hyaluronate ophthalmic solution (Hyalein®; Santen Pharmaceutical Co., Ltd.,
      Osaka, Japan) six times a day. Both groups instilled each eye drop from postoperative day 1
      to postoperative week 12.

      Participants: Consecutive patients aged 20-90 years with bilateral or unilateral cataract
      undergoing uncomplicated phacoemulsification and intraocular lens (IOL) implantation at
      Soonchunhyang University Hospital between January 2014 and January 2015 were enrolled. The
      inclusion criteria were patients with mild to moderate dry eye (level 1 or 2) based on the
      dry eye severity scale adopted by the Dry Eye Workshop (DEWS) report and who used only
      artificial tears occasionally1, and patients without or with mild blepharitis.18 The
      exclusion criteria were presence of any complications after cataract surgery such as cystoid
      macular edema, patients using any topical eye drops on a regular basis, treatment history of
      dry eye beyond artificial tears, any ocular surgery within the prior 6 months, contact lens
      wear, serious ocular surface disease (e.g., Sjögren's syndrome, ocular pemphigoid,
      conjunctival scarring, chemical injury), lacrimal or eyelid disease (e.g., moderate to severe
      blepharitis18), use of concomitant medications that could cause dry eye (e.g.,
      antihistamines, antidepressants, decongestants, anticholinergic drugs), and allergy to any of
      the study medications.

      Objective and subjective clinical assessments of dry eye: All patients underwent ophthalmic
      examinations preoperatively and postoperatively in the order of following : uncorrected
      distant visual acuity (UDVA) test, an ocular surface disease index (OSDI) questionnaire,
      Schirmer I test without anesthesia, changes in HOAs after blinking, tear break-up time
      (TBUT), corneal fluorescein staining, and lissamine green (LG) conjunctival staining. Eyelid
      and anterior chamber cells were evaluated by slit-lamp biomicroscopy to assess the presence
      of blepharitis/meibomian gland plugging and intraocular inflammation. Routine postoperative
      examinations were scheduled for 1 week, 4 weeks, and 12 weeks after surgery.

      Efficacy and safety evaluation: To evaluate the efficacy of the two different eye drops, we
      compared each measurement between the two groups throughout the study period, and at each
      follow-up, and also compared the patterns of changes in each group to identify which group
      recovered earlier. we evaluated the safety of the two eye drops, including anterior chamber
      inflammation and discontinuation of the eye drops due to drug-related discomfort. Patients
      that had any adverse events or wanted to stop using the eye drops were excluded from the
      study, but these patients were included in the safety evaluation.

      Surgical procedure: A 2.8 mm clear corneal incision was made at the location of the steep
      corneal astigmatism axis. A standard phacoemulsification technique was used with topical
      anesthesia with 2% lidocaine. A foldable IOL was implanted into the capsular bag. There was
      no suture at the corneal incision site. Patients received moxifloxacin (Vigamox; Alcon, Fort
      Worth, TX), which is a preservative-free formulation, and rimexolone (Vexol; Alcon), which
      contains 0.01% BAK, four times a day after surgery for 4 weeks.

      Statistical analysis: For statistical analysis, UDVA was converted from Snellen into logMAR
      values. Baseline data were compared between the groups using the Mann-Whitney U-test,
      Fisher's exact test, and the linear mixed model after adjusting for inter-eye correlations,
      age, and sex. In addition, another mixed model was used to compare measurement data between
      the two groups by considering the correlation between both eyes of each patient at each
      follow-up. To obtain an overall comparison between treatment responses throughout the study
      period considering the two levels of correlation in subjects and follow-up, a bivariate
      generalized linear mixed (GLM) model with asymmetric random effects was used. In the last
      step, a bivariate GLM model was also used to identify the patterns of changes in measured
      data throughout the study period. The intergroup differences in adverse events were analyzed
      using Fisher's exact test. SPSS software (version 21, SPSS, Inc., Chicago, IL) was used for
      all statistical analyses, and P < .05 was taken to indicate statistical significance.
    

Intervention name(s): Diquafosol (Diquas); Sodium Hyaluronate (Hyalein)
Intervention type(s): Drug; Drug
Intervention description(s): Diquafosol group used diquafosol 6 times a day during study period.; Hyaluronate group used sodium hyaluronate 6 times a day during study period.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment