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

Sponsor
Technolas Perfect Vision GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT01373853
Collaborator
(none)
131
Enrollment
1
Location
2
Arms
8
Duration (Months)
16.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Lens Fragmentation by means of a femtosecondlaser
  • Procedure: Manual Phacoemulsification
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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. [at time of surgery]

Secondary Outcome Measures

  1. 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. [1-Day Follow-UP]

  2. Less or equal severe adverse events in Group A compared to group B. p<0.05 will be considered statistically significant. [1-Day Follow-UP]

  3. Easy of phacoemulsification as subjectively perceived by the surgeon during surgery [time fo surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. (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

Locations

Site City State Country Postal Code
1 Maxivision Eye Hospital Hyderabad Andhra Pradesh India 500082

Sponsors and Collaborators

  • Technolas Perfect Vision GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01373853
Other Study ID Numbers:
  • 1103
First Posted:
Jun 15, 2011
Last Update Posted:
May 20, 2015
Last Verified:
May 1, 2015
Keywords provided by Technolas Perfect Vision GmbH
Lens Fragmentation
Cataract
Phacoemulsification
Femtosecond Laser
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of May 20, 2015