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A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery

This study is currently recruiting participants.
Verified March 2013 by Technolas Perfect Vision GmbH
Sponsor:
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:
NCT01769313
First received: January 14, 2013
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized, prospective, single-center, multi-surgeon, investigator masked study to investigate whether the femtolaser cataract surgery causes any significant differences in the resulting Intra Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of mass.


Condition Intervention Phase
Cataract
 Device: Laser-assisted cataract surgery
Device: Manually performed cataract surgery
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • ΔROverlap is different between Group A and Group B [ Time Frame: 6 Month postoeprative ] [ Designated as safety issue: No ]

    • The decentration, ΔROverlap, between implanted IOL and capsulotomy aperture is different in Group A as compared to Group B. p<0.05 will be considered statistically significant.

    The study end point will be determined for all follow-up examination periods; the purpose criterion should be achieved by the 6 month examination at the latest.

    Goal:To evaluate a significant difference (p<0.05) of ΔROverlap between Group A and Group B



Secondary Outcome Measures:
  • ΔELP is different between Group A and Group B [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]

    • The difference, Δ Flare, between preoperative and postoperative is different for Group A as compared to group B. p<0.05 will be considered statistically significant.

    The study end point will be determined 1-Day and 1-Week follow-up examination periods; the purpose criterion should be achieved by the 1-Week follow-up examination at the latest.

    Goal:

    To evaluate a significant difference (p<0.05) of Δ Flare between Group A and Group B


  • ΔFlare is different between Group A and Group B [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]

    • The difference, Δ Flare, between preoperative and postoperative is different for Group A as compared to group B. p<0.05 will be considered statistically significant.

    The study end point will be determined 1-Day and 1-Week follow-up examination periods; the purpose criterion should be achieved by the 1-Week follow-up examination at the latest.

    Goal:

    To evaluate a significant difference (p<0.05) of Δ Flare between Group A and Group B


  • SEQ Prediction Error is different between Group A and Group B [ Time Frame: 6 months postoperatvie ] [ Designated as safety issue: No ]

    • The difference, SEQ Prediction Error, between target refraction SEQ and actual SEQ is different in Group A as compared to Group B. p<0.05 will be considered statistically significant.

    The study end point will be determined for all follow-up examination periods, the purpose criterion should be achieved by the 6 month examination at the latest.

    Goal:

    To evaluate a significant difference (p<0.05) of the SEQ Prediction Error between Group A and Group B



Estimated Enrollment: 35
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
In Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
 Device: Laser-assisted cataract surgery
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Active Comparator: Group B
Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually.
 Device: Manually performed cataract surgery
The anterior capsulotomy and lens fragmentation will be performed manually.

Detailed Description:

A detailed pre-operative examination will ensure that every interested and willing patient fulfills the inclusion criteria of this study. For the proposed contralateral eye study between 30 and 35 patients will be enrolled whereas one eye will randomized undergo a manual cataract surgery and the other one a laser assisted cataract surgery. In total between 60 and 70 eyes will be included in the study. Pre-operative examinations are included to confirm to the clinical practice. Examinations on the day of surgery and any occurrence during the procedure are also listed. Post-operative examinations, which should document any occurrence, the outcome of and possible differences between the treatment techniques, are to be carried out after 1 day, 1 week, 1 month, 3 months and 6 months. After 6 month a final report including the study results will be produced.

The study is carried out in compliance with MEDDEV 2.7.1 Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies, ICH E6 (R1) Good Clinical Practice (GCP), Declaration of Helsinki as well as the applicable local regulations such as notification requirements and current order of profession of the primary investigators.

  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
  • Patients must have read, understood and signed the Patient Information
  • Patients are willing and able to return for follow-up examinations
  • Topographic Astigmatism ≤ 1.5 dpt
  • Patient will get a monofocal IOL (Envista) implanted

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 5D (exclusion criterium for Group A only)
  • The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D (exclusion criterium for Group A only)
  • Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light (exclusion criteria 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.
  • Manifest Glaucoma
  • Patients presenting a clear lens (clear lens exchange)
  • 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
  • Patients with keratoconus or keratectasia
  • Patients with connective tissue weakness
  • Patients who are blind on one eye
  • Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
  • Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable
  • Abnormal examination results from Orbscan (exclusion criteria for Group A only; , age related changes are acceptable
  • Patients who are pregnant or nursing
  • Patients who do not give informed consent
  • Patients with concentration disorders, epilepsy and other complicating diseases
  • Patients regularly taking medicines that could influence the result of the treatment
  • Patients who are participating in another ophthalmological clinical study
  • Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured as from the corneal endothelium.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769313

Contacts
Contact: Gerd U Auffarth, Prof. Dr. +49622156 ext 36631h ga@uni-hd.de
Contact: Mike Holzer, Prof. Dr. +49622156 ext 39614 Mike.Holzer@med.uni-heidelberg.de

Locations
Germany
Universitäts-Augenklinik Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Gerd U Auffarth, Prof. Dr.     +49622156 ext 36631     ga@uni-hd.de    
Principal Investigator: Gerd U Auffarth, Prof. Dr.            
Sub-Investigator: Mike Holzer, Prof. Dr.            
Sponsors and Collaborators
Technolas Perfect Vision GmbH
  More Information

No publications provided

Responsible Party: Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier: NCT01769313     History of Changes
Other Study ID Numbers: 1202
Study First Received: January 14, 2013
Last Updated: March 27, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Technolas Perfect Vision GmbH:
Cataract
Laser-assisted
Femtosecond

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 13, 2013