Cataract
Conditions
Keywords
Cataract, Laser-assisted, Femtosecond
Brief 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.
Interventions
DEVICELaser-assisted cataract surgery
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
DEVICEManually performed cataract surgery
The anterior capsulotomy and lens fragmentation will be performed manually.
Sponsors
Technolas Perfect Vision GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clear corneal media * Patients must be at least 18 years of age * Patients must have read, understood and signed the Patient Information * Patients are willing and able to return for follow-up examinations * Topographic Astigmatism ≤ 1.5 dpt * Patient will get a monofocal IOL (Envista) implanted
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 5D (exclusion criterium for Group A only) * The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D (exclusion criterium for Group A only) * Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ΔROverlap is different between Group A and Group B | 6 Month postoeprative | • The decentration, ΔROverlap, between implanted IOL and capsulotomy aperture is different in Group A as compared to Group B. p\<0.05 will be considered statistically significant. The study end point will be determined for all follow-up examination periods; the purpose criterion should be achieved by the 6 month examination at the latest. Goal:To evaluate a significant difference (p\<0.05) of ΔROverlap between Group A and Group B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ΔELP is different between Group A and Group B | 6 months postoperative | • The difference, Δ Flare, between preoperative and postoperative is different for Group A as compared to group B. p\<0.05 will be considered statistically significant. The study end point will be determined 1-Day and 1-Week follow-up examination periods; the purpose criterion should be achieved by the 1-Week follow-up examination at the latest. Goal: To evaluate a significant difference (p\<0.05) of Δ Flare between Group A and Group B |
| ΔFlare is different between Group A and Group B | 6 months postoperative | • The difference, Δ Flare, between preoperative and postoperative is different for Group A as compared to group B. p\<0.05 will be considered statistically significant. The study end point will be determined 1-Day and 1-Week follow-up examination periods; the purpose criterion should be achieved by the 1-Week follow-up examination at the latest. Goal: To evaluate a significant difference (p\<0.05) of Δ Flare between Group A and Group B |
| SEQ Prediction Error is different between Group A and Group B | 6 months postoperatvie | • The difference, SEQ Prediction Error, between target refraction SEQ and actual SEQ is different in Group A as compared to Group B. p\<0.05 will be considered statistically significant. The study end point will be determined for all follow-up examination periods, the purpose criterion should be achieved by the 6 month examination at the latest. Goal: To evaluate a significant difference (p\<0.05) of the SEQ Prediction Error between Group A and Group B |
Countries
Germany
Outcome results
None listed