Myopia Clinical Trial
— TEPEHERKAHMOfficial title:
Refractive Transepithelial Photo-keratectomy (T-PKR) Without Addition of Mitomycin-C in High Myopia: a Retrospective Study of 69 Eyes
Verified date | May 2021 |
Source | Centre Hospitalier Régional Metz-Thionville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Metz Thionville | Metz |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative uncorrected visual acuity (UCVA) at week 1 | Postoperative uncorrected visual acuity (UCVA) (logMAR) | Week 1 | |
Primary | Postoperative best spectacle corrected visual acuity (BSCVA) at week 1 | Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR) | Week 1 | |
Primary | Postoperative uncorrected visual acuity (UCVA) at month 1 | Postoperative uncorrected visual acuity (UCVA) (logMAR) | Month 1 | |
Primary | Postoperative uncorrected visual acuity (UCVA) at month 3 | Postoperative uncorrected visual acuity (UCVA) (logMAR) | Month 3 | |
Primary | Postoperative best spectacle corrected visual acuity (BSCVA) at month 1 | Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR) | Month 1 | |
Primary | Postoperative best spectacle corrected visual acuity (BSCVA) at month 3 | Postoperative best spectacle corrected visual acuity (BSCVA) (logMAR) | Month 3 | |
Secondary | Visual acuity efficacy index | 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. | 3 months | |
Secondary | Visual acuity safety index | 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. |
3 months | |
Secondary | Predictability | Predictability was defined as the percentage of eyes having reached target refraction (± 0.5D) at the end of follow-up (3 months). | 3 months | |
Secondary | Postoperative corneal haze measurement at week 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 |
Week1 | |
Secondary | Postoperative corneal haze measurement at 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 |
Month 1 | |
Secondary | Postoperative corneal haze measurement at 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 |
Month 3 | |
Secondary | postoperative spherical equivalent | Percent of postoperative spherical equivalent D (SD) | 3 months | |
Secondary | Postoperative refractive astigmatism at +/- 0.5D of target | Percent of eyes within +/- 0.5D of target | 3 months | |
Secondary | Postoperative refractive astigmatism at +/- 1.0D of target | Percent of eyes within +/- 1.0D of target | 3 months | |
Secondary | Complications | Percent of postoperative infections or epithelial healing | Up to 3 months | |
Secondary | Patient sex | Sex ratio Men/Women (percent) | Before surgery | |
Secondary | Patient age | Age (years) | Before surgery | |
Secondary | Preoperative Myopia | Myopia (Diopters) | Before surgery | |
Secondary | Preoperative Astigmatism | Astigmatism (Diopters) | Before surgery | |
Secondary | Preoperative Spherical equivalence | Spherical equivalence (Diopters) | Before surgery | |
Secondary | Preoperative best spectacle corrected visual acuity | BSCVA (logMAR) | Before surgery | |
Secondary | Preoperative Keratometry | Keratometry (dipoters) | Before surgery | |
Secondary | Preoperative central corneal thickness | central corneal thickness (µm) | Before surgery | |
Secondary | Preoperative optical and transition zones | Optical and transition zones (mm) | Before surgery | |
Secondary | Preoperative total ablation thickness | Total ablation thickness (µm) | Before surgery |
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