Dry EyeNCT03640351
Clinical Effects of Diquas-S for Patients With Dry Eye After Cataract Surgery
A study testing 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery, 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery and 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery in people with Dry Eye and Cataract Surgery, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye, Cataract Surgery
- What is being tested?
- 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery, 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery and 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Aug 2017to 13 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
- age of 20 years or older
- dry eye patient
Who cannot join
- 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,
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Yonsei Univeristy College of Medicine
Seoul, 03722
About this study
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.
Read the 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.
- Conditions
- Dry Eye, Cataract Surgery
- Being tested
- 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery, 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery, 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery
- Keywords
- Dry eye, Cataract surgery, Diquas, preservative free
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Preservative free diquafosol group | Active comparator | The subjects use preservative free diquafosol ophthalmic solution after cataract surgery Receives: 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 Receives: 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 Receives: Drug: 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Tear break up time (TBUT) at postoperative 3 months among the three groups.
- 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.
Measured: postoperative 3 months
2. Tear break up time (TBUT) changes between baseline and postoperative 3 months among the three groups.
- TBUT change from baseline to postoperative 3 months will be compared among the three groups.
Measured: postoperative 3 months
3. Ocular Surface Disease Index (OSDI) at postoperative 3 months among the three groups.
- 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.
Measured: postoperative 3 months
4. Ocular Surface Disease Index (OSDI) changes between baseline and postoperative 3 months among the three groups.
- OSDI change from baseline to postoperative 3 months will be compared among the three groups.
Measured: postoperative 3 months
5. Meibomian gland dysfunction (MGD) stage at postoperative 3 months among the three groups.
- 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.
Measured: 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.
Measured: postoperative 3 months
Secondary outcomes (2)
1. The value of total higher order aberration at postoperative 3 months among the three groups.
- 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.
Measured: postoperative 3 months
2. The change of the value of total higher order aberration between baseline and postoperative 3 months among the three groups.
- The change of the value of total higher order aberration from baseline to postoperative 3 months will be compared among the three groups.
Measured: postoperative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Aug 2017
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640351
- Sponsor's protocol ID
- 4-2017-0601
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2018
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27049809Lee 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.
PubMed 26989503Park 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.
PubMed 26685791Cui 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.
PubMed 28822028Inoue 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.
PubMed 28096651Lee 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.
PubMed 28222481
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Diquas-S for Patients With Dry Eye After Cataract Surgery
- ClinicalTrials.gov ID
- NCT03640351
- Acronym / sponsor ID
- 4-2017-0601
- Conditions
- Dry Eye, Cataract Surgery
- Keywords
- Dry eye, Cataract surgery, Diquas, preservative free
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preservative free diquafosol group | Active comparator | Drug: 1. Use of preservative free diquafosol ophthalmic solution after cataract surgeryThe subjects use preservative free diquafosol ophthalmic solution after cataract surgery |
| Preservative containing diquafosol group | Active comparator | Drug: 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgeryThe subjects use preservative containing diquafosol ophthalmic solution after cataract surgery |
| Preservative free sodium hyaluronate group | Active comparator | Drug: 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgeryThe subjects use preservative free sodium hyaluronate ophthalmic solution after cataract surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cataract
- age of 20 years or older
- dry eye patient
Key exclusion criteria (5 listed)
- 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,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Use of preservative free diquafosol ophthalmic solution after cataract surgeryParticipants 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 | Preservative free diquafosol group |
| 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgeryParticipants 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 | Preservative containing diquafosol group |
| 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgeryParticipants 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 | Preservative free sodium hyaluronate group |
Primary outcome
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.
2 secondary outcomes
1. The value of total higher order aberration at postoperative 3 months among the three groups.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Background: PubMed 27049809Baek 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.
- Background: PubMed 26989503Lee 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.
- Background: PubMed 26685791Park 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.
- Background: PubMed 28822028Cui 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.
- Background: PubMed 28096651Inoue 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.
- Background: PubMed 28222481Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery, 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery and 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery in people with Dry Eye and Cataract Surgery, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Tear break up time (TBUT) at postoperative 3 months among the three groups. (time frame: postoperative 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640351, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.