Refractive Error (Myopia)
Conditions
Interventions
Group 1:use diclofenac sodium and vitamin c before TPRK
Group 2:not use diclofenac sodium and vitamin c before TPRK
Sponsors
Shandong Eye Institute, Qingdao Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Patients must have-1.00D to-10.00D of manifest spherical equivalent myopiaand less than 1.5D astigmatism; 2. Patients must have had a stable refraction for the last 24 months as documented by previous clinical records, i.e., spherical or cylindrical portion of the manifest refraction has not progressed at a rate of more than +0.5D during the year prior to the baseline examination; 3. Patients who are hard (PMMA) contact lens wearers must discontinue their hard lenses for at least 4 weeks prior to the preoperative evaluation, and patients who are soft lens contact lens wearers must discontinue their lenses for at least 2 weeks prior to the preoperative evaluation. If the investigator determines that the topography is unaffected by contact lens use, surgery may be scheduled one week or less after the initial exam, with no contact lens wear permitted prior to the surgery; 4. For patients who are contact lens wearers, if, on the day of scheduled surgery central simulated keratometry readings and manifest refraction spherical equivalents do not differ significantly from the initial exam measurements (by more than 0.50 diopter), surgery may proceed. If the refractive change exceeds this criterion, the surgery should be rescheduled after refractive stability is achieved; 5. Patients best spectacle corrected visual acuity must be 20/20 or better in each eye; 6. Patients corneal topography must be normal; 7. Patients pupil size in dim condition must be smaller than 8mm and larger than 6mm as well (in order to minimize interference of the differences of pupil size); 8. Patients aged 21 to 35 years old; 9. Patients must sign a written Informed Consent form; 10. Patients must be able and willing to return for scheduled follow-up examinations for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Patients with residual, recurrent, or active ocular disease, corneal abnormality (specifically, recurrent corneal erosion, severe basement membrane disease, keratoconus, pellucid marginal degeneration), or previous corneal scarring in the treatment zone; 2. Patients who have irregularity in either left, right or both eyes; 3. Patients with ophthalmoscopic signs of progressive or unstable myopia; 4. Patients taking systemic medication likely to affect wound healing, such as corticosteroids or antimetabolites; 5. Patients who are immunocompromised or carrying diagnosis of connective tissue disease, or clinically significant atopic disease or diabetes; 6. Patients who have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of excimer laser surgery for either refractive or therapeutic purposes; 7. Patients with unstable central keratometry readings with irregular mires; 8. Patients who have a known sensitivity to study medication; 9. Patients who have a history of glaucoma or who are glaucoma suspect; 10. Patients who are participating in other ophthalmic clinical trials during this clinical investigation; 11. Patients who have a history of herpes simplex or herpes zoster keratitis; 12. Women who are pregnant, lactating, or planning to become pregnant over the course of this clinical investigation; 13. Patients who are at risk for developing strabismus after the treatment; 14. Patients with a systemic disease that would influence corneal wound healing, particularly collagen vascular diseases, including rheumatoid arthritis, systemic lupus, and Sj?grens syndrome; 15. Patients with nystagmus or any other condition which would prevent a steady gaze during surgery or other tests; 16. Patients with residual central corner thickness of less than 250 microns after subtracting the ablation depth.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain and discomfort;epithelial healing time;visual acurity;adverse effect;Haze; | — |
Countries
China
Contacts
Public ContactKeli Long
Shandong Eye Institute, Qingdao Eye Hospital
Outcome results
None listed