NCT03640351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

July 23, 2018

Last Update Submit

September 28, 2020

Conditions

Dry EyeCataract Surgery

Keywords

Dry eyeCataract surgeryDiquaspreservative free

Outcome Measures

Primary Outcomes (6)

  • 1. Tear break up time (TBUT) at postoperative 3 months among the three groups.

    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.

    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.

    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.

    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.

    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.

    6 MGD stage change from baseline to postoperative 3 months will be compared among the three groups.

    postoperative 3 months

Secondary Outcomes (2)

  • 1. The value of total higher order aberration at postoperative 3 months 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.

    postoperative 3 months

Study Arms (3)

Preservative free diquafosol group

ACTIVE COMPARATOR

The subjects use preservative free diquafosol ophthalmic solution after cataract surgery

Drug: 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery

Preservative containing diquafosol group

ACTIVE COMPARATOR

The subjects use preservative containing diquafosol ophthalmic solution after cataract surgery

Drug: 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery

Preservative free sodium hyaluronate group

ACTIVE COMPARATOR

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

Interventions

1. Use of preservative free diquafosol ophthalmic solution after cataract surgeryDRUG

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.

Preservative free diquafosol group
2. Use of preservative containing diquafosol ophthalmic solution after cataract surgeryDRUG

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.

Preservative containing diquafosol group
3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgeryDRUG

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.

Preservative free sodium hyaluronate group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract
  • age of 20 years or older
  • dry eye patient

You may not qualify if:

  • previous use of eye drops, except artificial tears within 3 months before cataract surgery,
  • presence of severe ocular surface diseases,
  • corneal epithelial pathologies except DE syndrome
  • a history of previous ocular surgery or trauma,
  • \. presence of ocular comorbidities such as glaucoma, uveitis, cystoid macular edema, 5. any surgical complications including rupture of the posterior capsule during cataract surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (6)

  • Baek J, Doh SH, Chung SK. The Effect of Topical Diquafosol Tetrasodium 3% on Dry Eye After Cataract Surgery. Curr Eye Res. 2016 Oct;41(10):1281-1285. doi: 10.3109/02713683.2015.1122813. Epub 2016 Apr 6.

    PMID: 27049809BACKGROUND

  • Lee JH, Song IS, Kim KL, Yoon SY. Effectiveness and Optical Quality of Topical 3.0% Diquafosol versus 0.05% Cyclosporine A in Dry Eye Patients following Cataract Surgery. J Ophthalmol. 2016;2016:8150757. doi: 10.1155/2016/8150757. Epub 2016 Feb 16.

    PMID: 26989503BACKGROUND

  • Park DH, Chung JK, Seo DR, Lee SJ. Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial. Am J Ophthalmol. 2016 Mar;163:122-131.e2. doi: 10.1016/j.ajo.2015.12.002. Epub 2015 Dec 11.

    PMID: 26685791BACKGROUND

  • Cui L, Li Y, Lee HS, Yang JM, Choi W, Yoon KC. Effect of diquafosol tetrasodium 3% on the conjunctival surface and clinical findings after cataract surgery in patients with dry eye. Int Ophthalmol. 2018 Oct;38(5):2021-2030. doi: 10.1007/s10792-017-0693-1. Epub 2017 Aug 18.

    PMID: 28822028BACKGROUND

  • Inoue Y, Ochi S. Effects of 3% diquafosol sodium ophthalmic solution on higher-order aberrations in patients diagnosed with dry eye after cataract surgery. Clin Ophthalmol. 2016 Dec 23;11:87-93. doi: 10.2147/OPTH.S122542. eCollection 2017.

    PMID: 28096651BACKGROUND

  • Lee H, Kim SM, Choi S, Seo KY, Kim EK, Kim TI. Effect of diquafosol three per cent ophthalmic solution on tear film and corneal aberrations after cataract surgery. Clin Exp Optom. 2017 Nov;100(6):590-594. doi: 10.1111/cxo.12521. Epub 2017 Feb 21.

    PMID: 28222481BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 21, 2018

Study Start

August 15, 2017

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)