Primary Disease: Cataract Clinical Trial
Official title:
Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre
This is a prospective, randomized study evaluating the circularity of the anterior
capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual
capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed
with cataract, scheduled to undergo removal by phacoemulsification with intraocular lens
implantation in SNEC.
The primary study end point is to determine if the circularity of the created rhexis is
better in Group A as compared to Group B.
The secondary study end point is to determine the diameter of rhexis is more precise and
reproducible in Group A as compared to Group B.
This clinical study is a controlled, open, randomized, prospective, single-centre,
single-surgeon eye study to determine the precision of intraocular cuts for anterior
capsulotomy in connection to cataract surgery and IOL implantation. The cuts are applied by
means of the VICTUS femtosecond laser system using a cylindrical cut pattern with diameter
and height dependent on anterior chamber depth, pupil diameter and ocular lens size for
Group A and the manual surgery technique for Group B.
The allocation of the surgery technique will be randomized between the study patient. Each
surgery technique represents a study group. In Group A the anterior capsulotomy and lens
fragmentation will be performed by means of femtosecond laser surgery. Group B acts as a
control group where the capsulotomy as well as the lens fragmentation is performed manually.
The hypothesis of the study is that by means of intraocular, laser-induced cuts, circularity
of the capsulotomy can be improved in a safe and effective way.
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 1-day, 1-week, 1-month.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment