CataractPhase 4NCT01769313
A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery
A Phase 4 study testing Laser-assisted cataract surgery and Manually performed cataract surgery in people with Cataract, run by Technolas Perfect Vision GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Laser-assisted cataract surgery and Manually performed cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 (exclusion criteria 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.
- Manifest Glaucoma
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- Patients presenting a clear lens (clear lens exchange)
- 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
- Patients with keratoconus or keratectasia
- Patients with connective tissue weakness
- Patients who are blind on one eye
- Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
- Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable
- Abnormal examination results from Orbscan (exclusion criteria for Group A only; , age related changes are acceptable
- Patients who are pregnant or nursing
- Patients who do not give informed consent
- Patients with concentration disorders, epilepsy and other complicating diseases
- Patients regularly taking medicines that could influence the result of the treatment
- Patients who are participating in another ophthalmological clinical study
- Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured as from the corneal endothelium.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- Laser-assisted cataract surgery, Manually performed cataract surgery
- Keywords
- Cataract, Laser-assisted, Femtosecond
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-assisted cataract surgeryDevice
The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
Manually performed cataract surgeryDevice
The anterior capsulotomy and lens fragmentation will be performed manually.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery Receives: Device: Laser-assisted cataract surgery |
| Group B | Active comparator | Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually. Receives: Device: Manually performed cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔROverlap is different between Group A and Group B
- 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
Measured: 6 Month postoeprative
Secondary outcomes (3)
ΔELP is different between Group A and Group B
- 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
Measured: 6 months postoperative
ΔFlare is different between Group A and Group B
- 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
Measured: 6 months postoperative
SEQ Prediction Error is different between Group A and Group B
- 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
Measured: 6 months postoperatvie
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerd U Auffarth, Prof. Dr., Principal investigator, Universitäts-Augenklinik Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769313
- Sponsor's protocol ID
- 1202
- Status last verified
- Oct 2014
- First submitted
- 14 Jan 2013
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery
- ClinicalTrials.gov ID
- NCT01769313
- Acronym / sponsor ID
- 1202
- Conditions
- Cataract
- Keywords
- Cataract, Laser-assisted, Femtosecond
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Laser-assisted cataract surgeryIn Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery |
| Group B | Active comparator | Device: Manually performed cataract surgeryGroup B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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 (exclusion criteria 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser-assisted cataract surgeryThe anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery | Device | Group A |
| Manually performed cataract surgeryThe anterior capsulotomy and lens fragmentation will be performed manually. | Device | Group B |
Primary outcome
ΔROverlap is different between Group A and Group B
Time frame: 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
3 secondary outcomes
ΔELP is different between Group A and Group B
Time frame: 6 months postoperative
ΔFlare is different between Group A and Group B
Time frame: 6 months postoperative
SEQ Prediction Error is different between Group A and Group B
Time frame: 6 months postoperatvie
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd U Auffarth, Prof. Dr. principal investigator
Universitäts-Augenklinik Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laser-assisted cataract surgery and Manually performed cataract surgery in people with Cataract, run by Technolas Perfect Vision GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔROverlap is different between Group A and Group B (time frame: 6 Month postoeprative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.