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

September 28, 2020 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Ophthalmology, Yonsei Univeristy College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Preservative free diquafosol group
The subjects use preservative free diquafosol ophthalmic solution after cataract surgery
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.
Active Comparator: Preservative containing diquafosol group
The subjects use preservative containing diquafosol ophthalmic solution after cataract surgery
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.
Active Comparator: Preservative free sodium hyaluronate group
The subjects use preservative free sodium hyaluronate ophthalmic solution after cataract surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative 3 months
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.
postoperative 3 months
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.
postoperative 3 months
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.
postoperative 3 months
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.
postoperative 3 months
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.
postoperative 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative 3 months
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.
postoperative 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Actual)

February 13, 2019

Study Completion (Actual)

February 13, 2019

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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