A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery

Cataract Clinical Trial

— 1103  

Official title:

A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373853
• Other study ID #: 1103
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2011
• Last updated: May 19, 2015
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2015
• Source: Technolas Perfect Vision GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clear corneal media

• Patients must be at least 18 years of age.

Exclusion Criteria:

• On a keratometric map of the cornea, the minimal and maximal K-values of the central 3mm zone must not differ by more than 5 dioptres. (exclusion criterium for Group A only)

• The maximum K- value may not exceed 60 D, the minimal value may not be smaller than 37 D. (exclusion criterium for Group A only)

• Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light. (exclusion criterium for Group A only)

• Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally.

• Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.

• Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.

• Known sensitivity to planned concomitant medications.

• Patients with disorders of the ocular muscle, such as nystagmus or strabismus

• Keratoconus

• Patients with woundhealing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis

• Abnormal examination results from slit lamp, Fundus, IOL Master

• Abnormal examination results from Orbscan (exclusion criterium for Group A only)

• Patients with an autoimmune disease, collagenosis or clinically significant atopy.

• Patients who are pregnant or nursing.

• Patients who do not give informed consent.

• ACD < 2.4 mm or ACD > 4.5 mm as measured by ultrasonic examination (exclusion criterium for Group A only)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Lens Fragmentation by means of a femtosecondlaser
In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.
• Manual Phacoemulsification
Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually

Locations

Country	Name	City	State
India	Maxivision Eye Hospital	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Technolas Perfect Vision GmbH

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation of the applied Effective Phaco Time (EPT) for Pahcoemulsifikation during surgery. The observed Effective Phaco Time in Group A should be significantly lower than in group B. Statistically significant difference at p<0.05.		at time of surgery	No
Secondary	Less or equal adverse events in Group A compared to group B (e.g. retinal detachment, IOL malposition). p<0.05 will be considered statistically significant.		1-Day Follow-UP	Yes
Secondary	Less or equal severe adverse events in Group A compared to group B. p<0.05 will be considered statistically significant.		1-Day Follow-UP	Yes
Secondary	Easy of phacoemulsification as subjectively perceived by the surgeon during surgery		time fo surgery	No