A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery
NCT ID: NCT01373853
Last Updated: 2015-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
131 participants
INTERVENTIONAL
2011-04-30
2011-12-31
Brief Summary
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The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation the required ultrasound energy used for phacoemulsification can be reduced in a safe and effective way.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Femtec Groupe A
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery
Lens Fragmentation by means of a femtosecondlaser
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.
Manual Group B
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
Manual Phacoemulsification
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
Interventions
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Lens Fragmentation by means of a femtosecondlaser
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.
Manual Phacoemulsification
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
Eligibility Criteria
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Inclusion Criteria
* Patients must be at least 18 years of age.
Exclusion Criteria
* The maximum K- value may not exceed 60 D, the minimal value may not be smaller than 37 D. (exclusion criterium for Group A only)
* Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light. (exclusion criterium for Group A only)
* Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally.
* Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
* Known sensitivity to planned concomitant medications.
* Patients with disorders of the ocular muscle, such as nystagmus or strabismus
* Keratoconus
* Patients with woundhealing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis
* Abnormal examination results from slit lamp, Fundus, IOL Master
* Abnormal examination results from Orbscan (exclusion criterium for Group A only)
* Patients with an autoimmune disease, collagenosis or clinically significant atopy.
* Patients who are pregnant or nursing.
* Patients who do not give informed consent.
* ACD \< 2.4 mm or ACD \> 4.5 mm as measured by ultrasonic examination (exclusion criterium for Group A only)
18 Years
ALL
No
Sponsors
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Technolas Perfect Vision GmbH
INDUSTRY
Responsible Party
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Locations
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Maxivision Eye Hospital
Hyderabad, Andhra Pradesh, India
Countries
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Other Identifiers
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1103
Identifier Type: -
Identifier Source: org_study_id
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