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Trial record 75 of 166 for:    PEMT

Clinical Effects of Diquas-S for Patients With Dry Eye After Cataract Surgery

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ClinicalTrials.gov Identifier: NCT03640351
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE July 23, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE August 15, 2017
Estimated Primary Completion Date August 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • 1. Tear break up time (TBUT) at postoperative 3 months among the three groups. [ Time Frame: postoperative 3 months ]
    1. Tear break up time (TBUT) is examined using slit lamp examination, The unit of this is "sec". Tear break up time (TBUT) at postoperative 3 months will be compared among the three groups.
  • 2. Tear break up time (TBUT) changes between baseline and postoperative 3 months among the three groups. [ Time Frame: postoperative 3 months ]
    2. TBUT change from baseline to postoperative 3 months will be compared among the three groups.
  • 3. Ocular Surface Disease Index (OSDI) at postoperative 3 months among the three groups. [ Time Frame: postoperative 3 months ]
    3. Ocular Surface Disease Index (OSDI) is examined using questionnaire evaluating dry eye symptom of patient (from 0 to 100). Ocular Surface Disease Index (OSDI) at postoperative 3 months will be compared among the three groups.
  • 4. Ocular Surface Disease Index (OSDI) changes between baseline and postoperative 3 months among the three groups. [ Time Frame: postoperative 3 months ]
    4. OSDI change from baseline to postoperative 3 months will be compared among the three groups.
  • 5. Meibomian gland dysfunction (MGD) stage at postoperative 3 months among the three groups. [ Time Frame: postoperative 3 months ]
    5. MGD stage is evaluated by examiner (from 0 to 4). OSDI and MGD stage is unitless. MGD stage at postoperative 3 months will be compared among the three groups.
  • 6. Meibomian gland dysfunction (MGD) stage changes between baseline and postoperative 3 months among the three groups. [ Time Frame: postoperative 3 months ]
    6 MGD stage change from baseline to postoperative 3 months will be compared among the three groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03640351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • 1. The value of total higher order aberration at postoperative 3 months among the three groups. [ Time Frame: postoperative 3 months ]
    1. The value of total higher order aberration is examined using iTrace aberrometer (Tracey Technologies Corp. Houston, TX). The unit of those is "μm". The value of total higher order aberration at postoperative 3 months will be compared among the three groups.
  • 2. The change of the value of total higher order aberration between baseline and postoperative 3 months among the three groups. [ Time Frame: postoperative 3 months ]
    2. The change of the value of total higher order aberration from baseline to postoperative 3 months will be compared among the three groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Effects of Diquas-S for Patients With Dry Eye After Cataract Surgery
Official Title  ICMJE Clinical Effects of Diquas-S for Patients With Dry Eye After Cataract Surgery
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Methods: The subjects are randomly divided into three groups. Group 1 uses preservative diquafosol ophthalmic solution, Group 2 uses preservative containing diquafosol ophthalmic solution, and Group 3 uses preservative free sodium hyaluronate after cataract surgery. Before surgery, all patients underwent a detailed ophthalmological examination that included slit-lamp examination (Haag-Streit, Köniz, Switzerland), and dry eye parameters including tear breakup time (TBUT), schirmer test, ocular surface disease index (OSDI), and MGD staging. Corneal wavefront aberrations were measured using i-Trace (Tracey Technologies Corp. Houston, TX). All examinations were repeated at 1, and 3 months after surgery.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye
  • Cataract Surgery
Intervention  ICMJE
  • Drug: 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery
    Participants are randomly assigned into the preservative free diquafosol group (Group 1), the preservative containing diquafosol group (Group 2) or the hyaluronate group (Group 3) using a simple unrestricted randomization method by the controller. The group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3% diquafosol tetrasodium ophthalmic solution (Diquas; Santen Pharmaceutical Co, Ltd) 6 times a day and the group 3 uses 0.15% sodium hyaluronate ophthalmic solution (New Hyaluni 0.15%; Taejoon, Seoul, Korea) 6 times a day. All three groups instill each eye drop from postoperative day 1 to postoperative 12 weeks.
  • Drug: 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery
    Participants are randomly assigned into the preservative free diquafosol group (Group 1), the preservative containing diquafosol group (Group 2) or the hyaluronate group (Group 3) using a simple unrestricted randomization method by the controller. The group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3% diquafosol tetrasodium ophthalmic solution (Diquas; Santen Pharmaceutical Co, Ltd) 6 times a day and the group 3 uses 0.15% sodium hyaluronate ophthalmic solution (New Hyaluni 0.15%; Taejoon, Seoul, Korea) 6 times a day. All three groups instill each eye drop from postoperative day 1 to postoperative 12 weeks.
  • Drug: 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery
    Participants are randomly assigned into the preservative free diquafosol group (Group 1), the preservative containing diquafosol group (Group 2) or the hyaluronate group (Group 3) using a simple unrestricted randomization method by the controller. The group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3% diquafosol tetrasodium ophthalmic solution (Diquas; Santen Pharmaceutical Co, Ltd) 6 times a day and the group 3 uses 0.15% sodium hyaluronate ophthalmic solution (New Hyaluni 0.15%; Taejoon, Seoul, Korea) 6 times a day. All three groups instill each eye drop from postoperative day 1 to postoperative 12 weeks.
Study Arms  ICMJE
  • Active Comparator: Preservative free diquafosol group
    The subjects use preservative free diquafosol ophthalmic solution after cataract surgery
    Intervention: Drug: 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery
  • Active Comparator: Preservative containing diquafosol group
    The subjects use preservative containing diquafosol ophthalmic solution after cataract surgery
    Intervention: Drug: 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery
  • Active Comparator: Preservative free sodium hyaluronate group
    The subjects use preservative free sodium hyaluronate ophthalmic solution after cataract surgery
    Intervention: Drug: 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 14, 2019
Estimated Primary Completion Date August 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Cataract
  2. age of 20 years or older
  3. dry eye patient

Exclusion Criteria:

  1. previous use of eye drops, except artificial tears within 3 months before cataract surgery,
  2. presence of severe ocular surface diseases,
  3. corneal epithelial pathologies except DE syndrome
  4. a history of previous ocular surgery or trauma,

4. presence of ocular comorbidities such as glaucoma, uveitis, cystoid macular edema, 5. any surgical complications including rupture of the posterior capsule during cataract surgery.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03640351
Other Study ID Numbers  ICMJE 4-2017-0601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP