Clinical Trial: Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

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

Official Title: Intrastromal Presbyopia Correction by Means of a Femtosecond Laser

Brief Summary: This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.

Detailed Summary:

This clinical study is an open, prospective, multi-centre eye study consisting of three study arms to determine the safety and efficacy of intrastromal incisions for the correction of visual acuity on presbyopic eyes. The incisions are applied by means of the FEMTEC femtosecond laser system with the INTRACOR software module using patterns consisting of 6 concentric rings and 3 different inner ring diameters. A similar pattern with 5 concentric rings and only one fixed inner diameter is currently under clinical investigation.

The hypothesis of the study is that by means of intrastromal incisions, near visual acuity can be improved in presbyopic eyes in a safe and effective way.

The intrastromal incisions are performed by the femtosecond laser FEMTEC, which is CE certified for various therapeutic indications. The incision eliminates both an epithelial and an endothelial opening of the cornea whereby the minimally invasive character of this form of treatment is guaranteed. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 24 hours, 1 week, 1 month, 3 months and 6 months.

Sponsor: Technolas Perfect Vision GmbH

Current Primary Outcome: The proportion of treated eyes who gained uncorrected near visual acuity of at least 2 lines. This proportion should be greater than 70%. [ Time Frame: 6 months follow up ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The proportion of treated eyes that lose more than two lines of best corrected visual acuity (BSCVA). This proportion should be no greater than 5 %. [ Time Frame: 6 months follow up ]

Original Secondary Outcome: Same as current

Information By: Technolas Perfect Vision GmbH

Dates:
Date Received: November 25, 2009
Date Started: December 2009
Date Completion:
Last Updated: June 8, 2011
Last Verified: June 2011