Clinical Investigation of ReLEx hismile with the VisuMax femtosecond laser system

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00006141
• Date of registration: 27/06/2014
• Prospective Registration: Yes
• Primary sponsor: Carl Zeiss Meditec AG
• Public title: Clinical Investigation of ReLEx hismile with the VisuMax femtosecond laser system
• Scientific title: Clinical Investigation of ReLEx hismile with the VisuMax femtosecond laser system - ---
• Date of first enrolment: 02/03/2015
• Target sample size: 48
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00006141
• Study type: interventional
• Study design: Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: historical; Assignment: other; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Latvia, Switzerland, United Kingdom

Contacts

• Name: Regina Schütt
• Affiliation: Carl Zeiss Meditec AG

• Name: Dan Reinstein
• Affiliation: London Vision Clinic Laser Eye Surgery

Key inclusion & exclusion criteria

Inclusion criteria: -Subjects should be 18 years of age or older
-Calculated residual stromal thickness (RST)>250 µm
-Normal corneal topography
- Contact lens wearers must stop wearing their rigid or soft contact lenses before baseline measurements according to local requirements of the clinic
-Distance refraction must be stable within the last twelve months
-only myopic patients or patients with myopia and astigmatism (sphere within -0.50D to -10.00D, cylinder up to 5.00D)
-The corrected distance visual acuity shall be 20/25 or better in each eye pre-operatively.
-Patients with a wavefront analysis diameter of at least 5mm (undilated) pre-OP
-Patient shall be able to understand the patient information and willing to sign an informed consent
-Patient shall be willing to comply with all follow-up visits



Exclusion criteria: • Previous intraocular or corneal surgery of any kind on the eye being treated.
• Intake of systemic medications which affect wound healing (e.g. corticosteroids)
• Treatment with medications such as steroids or immune-suppressants
• Diagnosis of an autoimmune disease, connective tissue disease or diabetes
• Unstable central keratometry readings with irregularities
• Herpes simplex or herpes zoster keratitis
• The patient is not able to lie flat in a horizontal position
• The patient cannot make him/herself understood and react to instructions
• The patient does not tolerate local or topical anaesthesia
• Pregnant or nursing women (or women, who planning pregnancy during the study)
• Any residual, recurrent or acute ocular disease or abnormality of the eye, e.g.
– Cataract
– Suspected glaucoma or an intraocular pressure >21 mm of Hg
– Corneal disease
– Corneal thinning disorder, e.g. keratoconus,
– Pellucid marginal corneal degeneration
– Dystrophy of the basal membrane
– Corneal oedema
– Exudative macular degeneration
– Infection
Any residual, recurrent, or active abnormality of the cornea to be treated, e.g.
- Existing corneal implant
- Corneal lesion
- Unstable refraction
- Connective tissue disease
- Dry eye, Sicca

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

H52

Disorders of refraction and accommodation

Intervention(s)

Group 1: ReLEx hismile: Refractive correction of myopia and myopia with astigmatism with the VisuMax femtosecond laser system by an aspheric design of the corneal lenticule
Group 2: ReLEx smile: Historical data of a refractive correction of myopia and myopia with astigmatism with the VisuMax femtosecond laser system by a spheric design of the corneal lenticule

Primary Outcome(s)

The principal objective of the study is to investigate the aspheric profile using ReLEx hismile as a treatment option compared to the current ReLEx smile spherical profile.
The focus of the research is to measure the change in the so called spherical aberration as a measure of optical quality. Spherical aberration will be measured using both a corneal topographer and a wavefront aberrometer at each visit.

Secondary Outcome(s)

The secondary objective of the study will be an extensive analysis of the refractive and visual outcomes at each follow-up visit. This analysis will follow the routine analysis of data in refractive surgery research. The study will also include analysis of corneal surface data (topography) and whole eye optics (wavefront aberrometry). Objective and subjective visual quality will also be assessed by measuring contrast sensitivity and by using a patient questionnaire pre- and postoperative.

Secondary ID(s)

CIV-14-03-011924

Source(s) of Monetary Support

Carl Zeiss Meditec AG

Ethics review

Status: Approved
Approval date: 20/06/2014
Contact:

South East Scotland Research Ethics Committee 02 [South East Scotland Research Ethics Committee 02 Edinburgh]

01315369000

Results

• Date Completed: 19/12/2016
• URL: http://drks.de/search/en/trial/DRKS00006141#studyResults