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A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery (1103)

This study has been completed.
Sponsor:
Information provided by:
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01373853
First received: June 8, 2011
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size.

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.


Condition Intervention Phase
Cataract
Procedure: Lens Fragmentation by means of a femtosecondlaser
Procedure: Manual Phacoemulsification
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • Observation of the applied Effective Phaco Time (EPT) for Pahcoemulsifikation during surgery. The observed Effective Phaco Time in Group A should be significantly lower than in group B. Statistically significant difference at p<0.05. [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Less or equal adverse events in Group A compared to group B (e.g. retinal detachment, IOL malposition). p<0.05 will be considered statistically significant. [ Time Frame: 1-Day Follow-UP ] [ Designated as safety issue: Yes ]
  • Less or equal severe adverse events in Group A compared to group B. p<0.05 will be considered statistically significant. [ Time Frame: 1-Day Follow-UP ] [ Designated as safety issue: Yes ]
  • Easy of phacoemulsification as subjectively perceived by the surgeon during surgery [ Time Frame: time fo surgery ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Procedure: 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.
Active Comparator: Manual Group B
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
Procedure: Manual Phacoemulsification
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clear corneal media
  • Patients must be at least 18 years of age.

Exclusion Criteria:

  • On a keratometric map of the cornea, the minimal and maximal K-values of the central 3mm zone must not differ by more than 5 dioptres. (exclusion criterium for Group A only)
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373853

Locations
India
Maxivision Eye Hospital
Hyderabad, Andhra Pradesh, India, 500082
Sponsors and Collaborators
Technolas Perfect Vision GmbH
  More Information

No publications provided

Responsible Party: Dr. Kasu Prasad Reddy, MaxiVision Eye Clinic
ClinicalTrials.gov Identifier: NCT01373853     History of Changes
Other Study ID Numbers: 1103
Study First Received: June 8, 2011
Last Updated: December 16, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Technolas Perfect Vision GmbH:
Lens Fragmentation
Cataract
Phacoemulsification
Femtosecond Laser

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 23, 2014