Compare the Clinical Efficacy of 3% Diquafosol and 0.1% Hyaluronic Acid in Patients with Dry Eye After Trans-PRK

NCT06852105 | Not Yet Recruiting

• 1 other identifier: PRK2025
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

The prevalence of refractive ametropia is rising year by year. Refractive surgery has become the main approach for adults to correct refractive ametropia, and postoperative complications have aroused extensive attention from clinicians. Dry eye after refractive surgery is one of the postoperative complications, which is an important cause of affecting the postoperative visual quality and satisfaction of patients. It was reported that 3% diquafosol (DQS) and 0.1% hyaluronic acid (HA) can relieve dry eye symptoms. This study aims to compare the efficacy of 3% DQS and 0.1% HA in treating dry eye after Trans-PRK

Conditions

Dry Eye; Tear Break-Up Time

Keywords

dry eye; Trans-PRK

Outcome Measures

Primary Outcomes (1)

• Non-invasive tear break-up time (NITBUT)

  The Keratograph 5M (Oculus, Germany) topographer will assess non-invasive tear breakup time.Three sequential readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.

  day 1, week 1, week 4, week 12 and week 24

Secondary Outcomes (9)

• Conjunctivocorneal staining (CS)

  day 1, week 1, week 4, week 12 and week 24

• Tear film lipid layer (TFLL) score

  day 1, week 1, week 4, week 12 and week 24

• Corneal Sensitivity Score

  day 1, week 1, week 4, week 12 and week 24

• Tear meniscus height (TMH)

  day 1, week 1, week 4, week 12 and week 24

• Conjunctival hyperemia (RS score):

  day 1, week 1, week 4, week 12 and week 24

Study Arms (2)

Study group

OTHER

dry eye patients after Trans-PRK

Drug: 3% Diquafosol Sodium Eye Drops

Control group

OTHER

dry eye patients after Trans-PRK

Drug: 0.1% hyaluronic acid

Interventions

3% Diquafosol Sodium Eye Drops DRUG

3% Diquafosol Sodium Eye Drops were instilled into the inferior conjunctival vault of both eyes

Study group

0.1% hyaluronic acid DRUG

0.1% sodium hyaluronate eye drops were instillation into the inferior conjunctival vault of both eyes

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years.
• The refractive status should be maintained at least for more than 2 years, during which the annual increase in myopia should be controlled within 0.50 D.
• Pherical equivalent (SE) ≤-6.00D, astigmatic power≤-2.00D.
• Best corrected vision before surgery≥1.0.
• Patients should stop wearing soft contact lenses for at least 2 weeks and hard contact lenses for at least 4 weeks before surgery.
• Postoperative corneal stromal thickness was preserved (280 μm).

You may not qualify if:

• Suspected of having keratoconus, a definite diagnosis of keratoconus, or another type of corneal dilatation disease.
• There is active inflammation or symptoms of infection in the eye.
• The thickness of the cornea does not meet the preset cutting depth requirement: the thickness of the central cornea should be greater than 450 μm, and the thickness of the central corneal stroma remaining under the corneal flap should be maintained above 250 μm after the intended cutting (280 μm recommended).
• Dry eye.
• There are serious lesions in the accessory structures of the eye, such as defects or deformations of the eyelids.
• People with uncontrolled systemic connective tissue diseases and autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis.

Sponsors & Collaborators

• He Eye Hospital: lead

Related Publications (7)

• Zaabaar E, Asiamah R, Kyei S, Ankamah S. Myopia control strategies: A systematic review and meta-meta-analysis. Ophthalmic Physiol Opt. 2025 Jan;45(1):160-176. doi: 10.1111/opo.13417. Epub 2024 Nov 12.

  PMID: 39530399 BACKGROUND

• Du Y, Di Y, Yang S, Li Y. Analysis of the changes in corneal optical density following small incision lenticule extraction for myopia and related influencing factors. Photodiagnosis Photodyn Ther. 2024 Dec;50:104397. doi: 10.1016/j.pdpdt.2024.104397. Epub 2024 Nov 9.

  PMID: 39528007 BACKGROUND

• Mu J, Zhong H, Jiang M, Wang J, Zhang S. Development of a nomogram for predicting myopia risk among school-age children: a case-control study. Ann Med. 2024 Dec;56(1):2331056. doi: 10.1080/07853890.2024.2331056. Epub 2024 Mar 20.

  PMID: 38507901 BACKGROUND

• Zhao L, Zhang Y, Duan H, Yang T, Ma B, Zhou Y, Chen J, Chen Y, Qi H. Clinical Characteristic and Tear Film Biomarkers After Myopic FS-LASIK: 1-Year Prospective Follow-up. J Refract Surg. 2024 Aug;40(8):e508-e519. doi: 10.3928/1081597X-20240514-05. Epub 2024 Sep 1.

  PMID: 39120023 BACKGROUND

• Hou X, Chen P, Yu N, Luo Y, Wei H, Zhuang J, Yu K. A Comparative and Prospective Study of Corneal Consumption and Corneal Biomechanics After SMILE and FS-LASIK Performed on the Contralateral Eyes With High Myopic Astigmatism. Transl Vis Sci Technol. 2024 Nov 4;13(11):29. doi: 10.1167/tvst.13.11.29.

  PMID: 39576656 BACKGROUND

• Yang F, Yang Z, Zhao S, Huang Y. To Investigate the Changes in Corneal Curvature and Its Correlation with Corneal Epithelial Remodeling After Trans-PRK and FS-LASIK. Curr Eye Res. 2024 Oct;49(10):1061-1067. doi: 10.1080/02713683.2024.2361728. Epub 2024 Jun 12.

  PMID: 38867491 BACKGROUND

• Su B, Cho P, Vincent SJ, Zheng J, Chen J, Ye C, Wang T, Zhang J, Zhang K, Lu F, Jiang J. Novel Lenslet-ARray-Integrated Spectacle Lenses for Myopia Control: A 1-Year Randomized, Double-Masked, Controlled Trial. Ophthalmology. 2024 Dec;131(12):1389-1397. doi: 10.1016/j.ophtha.2024.07.002. Epub 2024 Jul 6.

  PMID: 38972357 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Guanghao Qin Principal Investigator

CONTACT

+86-1884266442; qinguanghao2020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02