Refractive Transepithelial Photo-keratectomy (T-PKR) in High Myopia

Myopia Clinical Trial

— TEPEHERKAHM  

Official title:

Refractive Transepithelial Photo-keratectomy (T-PKR) Without Addition of Mitomycin-C in High Myopia: a Retrospective Study of 69 Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04917562
• Other study ID #: 2021-03-Obs-CHRMT
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2021
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Eye Diseases
• Keratopathy
• Myopia
• Ophthalmopathy

Locations

Country	Name	City	State
France	Centre Hospitalier Metz Thionville	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

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