Intrastromal Presbyopia Correction by Means of a Femtosecond Laser
Summary
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
Description
This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The incisions are applied by means of the FEMTEC femtosecond laser system with the INTRACOR software module using patterns consisting of 6 concentric rings and 3 different inner ring diameters. A similar pattern with 5 concentric rings and only one fixed inner diameter is currently under clinical investigation.
The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.
The intrastromal incisions are performed by the femtosecond laser FEMTEC, which is CE certified for various therapeutic indications. The incision eliminates both an epithelial and an endothelial opening of the cornea whereby the minimally invasive character of this form of treatment is guaranteed. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 24 hours, 1 week, 1 month, 3 months and 6 months.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Presbyopia
Intervention
Intrastromal Correction of Presbyopia
Location
University Eye Clinic Heidelberg
Heidelberg
Baden-Württemberg
Germany
69120
Status
Active, not recruiting
Source
Technolas Perfect Vision GmbH
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01025050
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:17:32-0400
Clinical Trials
Intrastromal Correction of Ametropia by a Femtosecond Laser
This study evaluates the intrastromal correction of ametropia with a femtosecond laser made by 20/10 PERFECT VISION. This laser generates a beam of ultrashort, infrared pulses which enable...
Presbyopia in Breast Cancer Survivors
Chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. Presbyopia is the inability to focus the eye on close objects, by a process...
Multicenter Evaluation of Safety and Effectiveness of Presbyopic LASIK for Hyperopes
The Presbyopia Algorithm subject to this study has been specifically developed to prospectively generate a treatment file for the Technolas 217z100 laser that will provide Presbyopia corre...
PROductivity Study of Presbyopia Elimination in Rural-dwellers (PROSPER)
This trial seeks to establish, using a randomized, controlled design, the impact of near eyesight correction on the productivity of presbyopic agricultural workers in India, as measured by...
Safety and Effectiveness of the AcuFocus Corneal Inlay ACI 7000PDT in Presbyopes
The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method for the correction of presbyopia in patients who have normal distance v...
PubMed Articles
Presbyopia treatment solution by Laser Surgery.
Today there are different options for correcting presbyopia by corneal laser procedure, but all of them have their benefits and compromises. The Monovision is a pseudoaccommodation procedure which wor...
In refractive surgery the removal of the natural lens followed by implantation of an artificial intraocular lens has been an established method to treat refractive errors. The term "clear lens exchang...
To compare clinical and quality of life outcomes between patients who underwent monovision LASIK and refractive lens exchange.
To compare the predictability of intrastromal tunnel depth creation for intrastromal corneal ring segments (ICRS) implantation between manual dissection and femtosecond laser using a high-resolution a...
Medical and Biotech [MESH] Definitions
Presbyopia
The normal decreasing elasticity of the crystalline lens that leads to loss of accommodation.
Programmed Instruction
Works consisting of sequenced self-correction texts.
Arterial Switch Operation
Surgical procedure for anatomical correction of transposed great arteries (e.g., DOUBLE OUTLET RIGHT VENTRICLE).
Correction Of Hearing Impairment
Procedures for correcting HEARING DISORDERS.
Retinoscopy
An objective determination of the refractive state of the eye (NEARSIGHTEDNESS; FARSIGHTEDNESS; ASTIGMATISM). By using a RETINOSCOPE, the amount of correction and the power of lens needed can be determined.
