Comparing sodium hyaluronate effects on eye moisture after cataract surgery
| ISRCTN | ISRCTN95830348 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95830348 |
- Submission date
- 10/08/2023
- Registration date
- 25/08/2023
- Last edited
- 31/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Cataracts are when the lens of your eye, a small transparent disc, develops cloudy patches. Cataract surgery involves replacing the cloudy lens inside the eye with an artificial one. Postoperative Dry Eye Syndrome (DES) often occurs after cataract surgery. Sodium hyaluronate eye solution is a common treatment for dry eye syndrome after cataract surgery. The aim of this study is to compare the efficacy of 0.15% sodium hyaluronate eye drops in MGD dysfunction and dry eye syndrome after cataract surgery in comparison with 0.1% sodium hyaluronate eye drops.
Who can participate?
Adult cataract patients with normal lid position and closure and not suffering from any eye diseases
What does the study involve?
Participants will be randomly allocated to use 0.15% or 0.1% sodium hyaluronate eye drops for 6 weeks following cataract surgery. Eye assessments are performed at each visit 1week before and 1, 3, 6 weeks after surgery.
What are the possible benefits and risks of participating?
There may be no risks or benefits for the participants. The eye drops are commercially available and have proven clinical safety.
Where is the study run from?
Pusan National University School of Medicine (South Korea)
When is the study starting and how long is it expected to run for?
February 2022 to December 2023
Who is funding the study?
Pusan National University Yangsan Hospital (South Korea)
Who is the main contact?
Dr Seungahn Yang
yangggoggo@naver.com
Contact information
Scientific
Pusan National University School of Medicine
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea, South
 ORCID ID |
0009-0000-2818-5172 |
|---|---|
| Phone | +82 (0)55 360 1447 |
| yangggoggo@naver.com |
Study information
| Study design | Prospective randomized double-masked comparative clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Efficacy of 0.15% sodium hyaluronate on tear breakup time (TBUT), Schirmer's I test score, ocular surface disease index (OSDI) score, corneal staining score (CSS), lipid layer thickness (LLT) and meiboscore after cataract surgery: a randomized, double-masked study |
| Study hypothesis | 0.15% sodium hyaluronate might improve ocular surface status and dry eye syndrome in comparison with 0.1% sodium hyaluronate after cataract surgery. |
| Ethics approval(s) |
Approved 06/05/2022, Pusan National University Yangsan Hospital Institutional Review Board (#20 Geumo-ro, Mulgeum-eup, Yangsan, 50612, Korea, South; +84 55 360 3854; pnyhirb@gmail.com), ref: 05-2022-084 |
| Condition | Dry eye syndrome, meibomian gland dysfunction |
| Intervention | Patients are randomized using the random number method into two treatment groups. The first group will use 0.15% sodium hyaluronate ophthalmic solution (Hyalu Mini®, Hanmi P harma Inc., Seoul, Korea) 4 times daily over 6 weeks following cataract surgery. The second group receive standard postoperative treatment with 0.1% sodium hyaluronate (HyalQ, Ildong Pharmaceutical Inc., Seoul, Korea) Eye assessments are performed at each visit 1 week before and 1, 3, 6 weeks after surgery. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 0.15% sodium hyaluronate ophthalmic solution (Hyalu Mini®, Hanmi P harma Inc., Seoul, Korea) 0.1% sodium hyaluronate (HyalQ, Ildong Pharmaceutical Inc., Seoul, Korea) |
| Primary outcome measure | Measured at baseline (1 week before cataract surgery) and 1, 3, 6 weeks after cataract surgery: 1. Ocular surface status parameters: 1.1. Lipid layer thickness (LLT) measured using an interferometer 1.2. Schirmer’s type I test using COLOR BAR by Eagle Vision Inc. 1.3. Tear breakup time (TBUT), corneal staining score(CSS), meiboscore were measured by an ophthalmologist 2. Patients’ symptoms measured using Ocular Surface Disease Index (OSDI) questionnaire |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 06/05/2022 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 70 |
| Participant inclusion criteria | 1. Be male or female, aged 19 years to 90 years 2. Have a tear breakup time (TBUT) of 10 seconds or more 3. Have a Schirmer’s I test result of 10 mm or more 4. Have not used diquafosol-based eye drops, artificial tear drops, steroid eye drops, or antibiotic eye drops within 3 months before participation 5. Show normal blinking during a slit lamp exam 6. Voluntarily agree to participate in this study |
| Participant exclusion criteria | 1. Has Sjögren's syndrome 2. Has severe blepharitis 3. Had ocular surgery or laser eye surgery 4. Has severe ocular inflammation/infection 5. Is using eye drop treatment for dry eyes, such as glaucoma or allergies 6. Shows sensitivity to the study drugs 7. Is considered to be ineligible for participation owing to reasons other than the aforementioned exclusion criteria based on the judgment of the principal researcher |
| Recruitment start date | 11/05/2022 |
| Recruitment end date | 30/11/2022 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
20-Geumo-ro
Mulgeum-eup
Yangsan
50612
Korea, South
Sponsor information
Hospital/treatment centre
20-Geumo-ro Mulgeum-eup
Yangsan
50612
Korea, South
| Phone | +82 (0)55 360 1447 |
|---|---|
| jiel75@hanmail.net | |
| Website | http://www.pnuyh.or.kr/pnuh/main/main.do?rbsIdx=1 |
"ROR" |
https://ror.org/04kgg1090 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 04/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/07/2024 | 31/07/2024 | Yes | No |
Editorial Notes
31/07/2024: Publication reference added.
21/08/2023: Trial's existence confirmed by Pusan National University Yangsan Hospital Institutional Review Board.
