Maxivision Eye Hospital
Hyderabad, Andhra Pradesh, 500082, India
NCT Number: NCT01373853
This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size.
The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation the required ultrasound energy used for phacoemulsification can be reduced in a safe and effective way.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Hyderabad, Andhra Pradesh, 500082, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
Time frame: at time of surgery
Time frame: 1-Day Follow-UP
Time frame: 1-Day Follow-UP
Time frame: time fo surgery
Technolas Perfect Vision GmbH
Industry
Acronym: 1103
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