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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Technolas Perfect Vision GmbH

Current Primary Outcome: ΔROverlap is different between Group A and Group B [ Time Frame: 6 Month postoeprative ]

• 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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ΔELP is different between Group A and Group B [ Time Frame: 6 months postoperative ]

    • 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 ]

    • 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 ]

    • 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



Original Secondary Outcome: Same as current

Information By: Technolas Perfect Vision GmbH

Dates:
Date Received: January 14, 2013
Date Started: January 2013
Date Completion:
Last Updated: October 30, 2014
Last Verified: October 2014