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Study on the effect of perioperative intervention of traditional Chinese medicine "Quguang Jueming Prescription" on postoperative corneal repair after Trans-PRK and its mechanism

Study on the effect of perioperative intervention of traditional Chinese medicine "Quguang Jueming Prescription" on postoperative corneal repair after Trans-PRK and its mechanism

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078532
Enrollment
Unknown
Registered
2023-12-12
Start date
2023-12-16
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-refractive surgery

Interventions

intervention group:In the perioperative period of Trans-PRK (1d postoperatively to 7d postoperatively), in addition to the usual postoperative medication, "Quguang Jueming Prescription"was added to or
control group:Use of conventional postoperative medications during the perioperative period of Trans-PRK (1d postoperative to 7d postoperative)

Sponsors

Ineye Hospital of Chengdu University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Patients who have a personal request for lens removal and choose to undergo Trans-PRK; (2) Age 18 to 55 years old; (3) Refractive status is basically stable (annual myopic refractive error increase not more than 0.50 D,=2 years); (4) Myopia in the range of -1.0 D ~ -6.0 D, astigmatism = -3.0 D, refractive therapy degree (the sum of spherical lens degree plus astigmatism, the sign is negative, the same after) = -8.0 D; (5) For those who wear corneal contact lenses, stop wearing soft corneal contact lenses for = 1 week, RGP lenses for = 1 month, and keratoplasty lenses for = 3 months before surgery; (6) The central corneal thickness =450 µm, and the calculated postoperative preserved corneal thickness =360 µm; (7) The patient should be psychologically and mentally healthy, fully understand and be able to accept the possible problems of the surgery, be psychologically prepared and tolerant to pain, be willing to participate in this clinical observation, attend the postoperative review on time, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those with active inflammatory diseases such as acute keratoconjunctivitis, corneal ulcer, blepharitis, or chronic dacryocystitis in the eye; (2) Those with ophthalmic diseases such as cone cornea, glaucoma, severe dry eye and severe fundus lesions; if there is a retinal tear in the fundus, retinal degeneration areas should be subjected to laser photocoagulation before surgery; (3) History of systemic contraindicated diseases (immune system diseases, connective tissue diseases, etc.), patients with severe keloid, diabetes and other systemic diseases; (4) Pregnant and lactating women; (5) Best corrected visual acuity <0.3; (6) Those who failed to attend the review on time and obtained incomplete observation data;

Design outcomes

Primary

MeasureTime frame
Corneal Epithelial Repair;Corneal Nerve Repair;Prostaglandin E2;Interleukin-6;

Secondary

MeasureTime frame
Pain classification; Pain duration;Corneal haze;Postoperative self-perceived symptoms;total higher-order aberration (THA);Comet aberration ;spherical aberration;Transforming Growth Factor-ß1;Tumor Necrosis Factor;

Countries

China

Contacts

Public ContactChunyang Zhou

Ineye Hospital of Chengdu University of TCM

zhouchunyang@cdutcm.edu.cn+86 139 8205 9090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026