NCT01769313

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Technolas Perfect Vision GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Laser-assisted cataract surgery	The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
DEVICE	Manually performed cataract surgery	The anterior capsulotomy and lens fragmentation will be performed manually.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-01-16
• Last updated: 2014-10-31

Locations

1 site across 1 country: Germany