Keratopathy, Myopia, Ophthalmopathy
Conditions
Keywords
transepithelial photorefractive keratectomy, high myopia, mitomycin-C, corneal haze, efficacy, predictibility
Brief summary
The aim of this study is to evaluate the anatomical and refractive parameters following a single-step transepithelial photo-refractive keratectomy (T-PRK) without the addition of mitomycin-C for the treatment of high myopia of 6 diopters or more.
Detailed description
In this retrospective study, 69 high myopic eyes of 6 diopters or more were treated in 38 patients by Trans-PRK with the SCHWIND Amaris 500E® excimer laser platform without the use of mitomycin-C. Several outcomes are measured in treated patients, such as postoperative uncorrected visual acuity (UCVA), best spectacle corrected visual acuity (BSCVA), efficacy, safety and predictability of the procedure, as well as corneal haze measurement. The patients are followed-up for 3 months.
Interventions
None listed
Sponsors
Centre Hospitalier Régional Metz-Thionville
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 years, * myopic sphere of -6 diopters or more, * astigmatism less than 3 diopters, * stable myopia not progressing for more than one year
Exclusion criteria
* age \<18 years, * myopic sphere less than -6 diopters, * astigmatism greater than 3 diopters, * progressive myopia (variation of more than 0.5 diopters over one year), * abnormal corneal topography or the presence of manifest keratoconus, * pre-existing eye pathology, * history of eye surgery, * active inflammatory or infectious eye disease, * dermatological disease or systemic connectivitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative uncorrected visual acuity (UCVA) at week 1 | Week 1 | Postoperative uncorrected visual acuity (UCVA) (logMAR) |
| Postoperative best spectacle corrected visual acuity (BSCVA) at week 1 | Week 1 | Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR) |
| Postoperative uncorrected visual acuity (UCVA) at month 1 | Month 1 | Postoperative uncorrected visual acuity (UCVA) (logMAR) |
| Postoperative uncorrected visual acuity (UCVA) at month 3 | Month 3 | Postoperative uncorrected visual acuity (UCVA) (logMAR) |
| Postoperative best spectacle corrected visual acuity (BSCVA) at month 1 | Month 1 | Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR) |
| Postoperative best spectacle corrected visual acuity (BSCVA) at month 3 | Month 3 | Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity efficacy index | 3 months | The efficacy of the procedure was defined by the proportion of eyes with uncorrected visual acuity at 3 months greater than or equal to Log MAR 0.1 (or 8/10 on a decimal scale). The efficacy index was defined as the ratio between the mean uncorrected visual acuity at 3 months and the best corrected visual acuity preoperatively. A threshold of 80% was required to consider the surgery successful. |
| Visual acuity safety index | 3 months | The safety of the procedure was defined as the proportion of eyes that lost 2 or more lines of visual acuity compared to the best preoperative corrected visual acuity. The safety index was defined as the ratio between the best corrected visual acuity 3 months postoperatively and the best corrected visual acuity preoperatively. An 80% threshold was chosen to consider the procedure safe. |
| Predictability | 3 months | Predictability was defined as the percentage of eyes having reached target refraction (± 0.5D) at the end of follow-up (3 months). |
| Postoperative corneal haze measurement at week 1 | Week1 | Corneal haze assessment was performed at each follow-up visit and reported on the Fantes scale * Grade 0: absence of corneal haze. * Grade 1: corneal fog that does not prevent the visibility of details of the iris * Grade 2: slight fading of details of the iris * Grade 3: pronounced erasure of details of the iris and lens * Grade 4: complete opacification of the stroma preventing access to the anterior chamber |
| Postoperative corneal haze measurement at month 1 | Month 1 | Corneal haze assessment was performed at each follow-up visit and reported on the Fantes scale * Grade 0: absence of corneal haze. * Grade 1: corneal fog that does not prevent the visibility of details of the iris * Grade 2: slight fading of details of the iris * Grade 3: pronounced erasure of details of the iris and lens * Grade 4: complete opacification of the stroma preventing access to the anterior chamber |
| Postoperative corneal haze measurement at month 3 | Month 3 | Corneal haze assessment was performed at each follow-up visit and reported on the Fantes scale * Grade 0: absence of corneal haze. * Grade 1: corneal fog that does not prevent the visibility of details of the iris * Grade 2: slight fading of details of the iris * Grade 3: pronounced erasure of details of the iris and lens * Grade 4: complete opacification of the stroma preventing access to the anterior chamber |
| postoperative spherical equivalent | 3 months | Percent of postoperative spherical equivalent D (SD) |
| Postoperative refractive astigmatism at +/- 0.5D of target | 3 months | Percent of eyes within +/- 0.5D of target |
| Postoperative refractive astigmatism at +/- 1.0D of target | 3 months | Percent of eyes within +/- 1.0D of target |
| Complications | Up to 3 months | Percent of postoperative infections or epithelial healing |
| Patient sex | Before surgery | Sex ratio Men/Women (percent) |
| Patient age | Before surgery | Age (years) |
| Preoperative Myopia | Before surgery | Myopia (Diopters) |
| Preoperative Astigmatism | Before surgery | Astigmatism (Diopters) |
| Preoperative Spherical equivalence | Before surgery | Spherical equivalence (Diopters) |
| Preoperative best spectacle corrected visual acuity | Before surgery | BSCVA (logMAR) |
| Preoperative Keratometry | Before surgery | Keratometry (dipoters) |
| Preoperative central corneal thickness | Before surgery | central corneal thickness (µm) |
| Preoperative optical and transition zones | Before surgery | Optical and transition zones (mm) |
| Preoperative total ablation thickness | Before surgery | Total ablation thickness (µm) |
Countries
France
Outcome results
None listed