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Key Points of Clinical Trial Protocol Design for Artificial Lens in China

from CIRS by


Mar 29th 2016, CFDA has issued Guiding Principle of Pre-market Clinical Trial for Artificial Lens (hereinafter referred to as “Guiding Principle”) to help manufacturer and clinical trial institutions to conduct clinical trial.

CIRS has compiled the Key Points of Clinical Trial Protocol Design for Artificial Lens according to this Guiding Principle.

1. Purpose and Precautions

The purpose of clinical trial is to evaluate the expected safety and effectiveness of product.
LogMAR visual chart (also known as EDTRS visual chart) is recommended to use in clinical trial. The result of optometry which involve with refraction examination, shall be subject to the value of subjective refraction (including spherical power and astigmatic power). The value of objective optometry shall be recorded and for a reference.

2. Clinical trial design

Clinical trial shall be foresighted, multi-centric, randomized and controlled. The contrast of clinical trial shall be the same product approved for marketing, and should pay attention to a reasonable choice of the contrast. It is recommended that the contrast shall be as close to tested product as possible, and can take materials, manufacturing processed, main function, implant site, etc. into consideration to get the contrast. The contrast and tested group shall adopt the same inclusion and exclusion criteria, and conduct test in according with the unit project. The observation and follow-up period shall be same.

3. Sample Size

The determination of sample size of clinical trial shall confirm to the clinical trial objective and statistics requirements. Applicant/Manufacturer shall provide the statistics argument which can prove that the sample size is sufficient to evaluate the safety and effectiveness of artificial lens, calculative process of sample size, importance parameter, dividing value and computational formula, statistics software, etc.
The size of tested product and the contrast shall be at a rate of 1 to 1. Subjects are required to set one eye in clinical trial. It is recommended that the size of effective cases shall be 74 pairs at least.

4. Follow-up Period

The follow-up period shall be 12 months at least, and can extend the period based on risk analysis. At the same time, shall set the time point of follow-up, including 1 day, 1 week, 1, 3, 6, 12 month after operation, ……, final time point.

5. Inclusion / Exclusion Criteria

Determining the inclusion criteria shall consider the application range of tested product. During enrolling process, shall consider the balance of intra-group and inter-group as far as possible on the foundation of random.
It is recommended that the following solutions shall be excluded to protect the right and interest of subjects.
  1. Best corrected visual acuity is greater than 0.5;
  2. Count of corneal endothelial cell is less than 2000 cell/mm2;
  3. Younger than 18years old;
  4. Pregnant and lactating women;
  5. The person who is taking part in the other clinical trial of medical device or drug.
Formulate the exit criteria of subject, and count the number of exiting subjects and results.

6. Performance index of effectiveness

The effectiveness performance index of clinical trial shall be recorded during follow-up. Effectiveness performance index shall include but are not limited to:
  1. Best corrected visual acuity;
No matter randomized and parallel method or single target value method, the main evaluation index shall be effective rate of product within half a year.
Effective Definition: it is effective while the best corrected visual acuity of tested eye is 0.5.
Shall list the Best corrected visual acuity on the 1 day, 1 week, 1, 3, 6, 12 month and final time after operation at least. If adopting randomized and parallel method, shall provide the statistical analysis result of Best corrected visual acuity.
  1. Diopter check
Shall list the Diopter on the 1 day, 1 week, 1, 3, 6, 12 month and final time after operation at least, and analyze the data of expected diopter and actual diopter. If adopting randomized and parallel method, shall provide the statistical analysis result.
  1. Uncorrected visual acuity
Shall list the Uncorrected visual acuity on the 1 day, 1 week, 1, 3, 6, 12 month and final time after operation at least. If adopting randomized and parallel method, shall provide the statistical analysis result.

7. Performance of Safety

The safety performance of clinical trial shall be including but not limited:
  1. 7.1 Symptom, sign, complication, adverse events, etc.
Shall list the symptom, sign, complication, adverse events of subjects on the 1 day, 1 week, 1, 3, 6, 12 month and final time after operation. If adopting randomized and parallel method, shall provide the statistical analysis result.
  1. 7.2 Eye examination
  • Corneal condition under slit lamp and Corneal endothelial cell count
Shall observe the corneal conditions under slit lamp and record the information about corneal edema and ruga, etc. shall count the corneal endothelial cell on the 1, 3, 6, 12 month and final time after operation. If adopting randomized and parallel method, shall provide the statistical analysis result.
  • Inflammatory reaction
Shall record the inflammatory reaction on the 1 day, 1 week, 1, 3, 6, 12 month and final time after operation, such as entophthalmia, aqueous flare, hypopyon, and so on.
  • Artificial lens condition
Shall record the o artificial lens condition on the 1 day, 1 week, 1, 3, 6, 12 month and final time after operation, such as off normal of artificial lens, incline, muddy etc.
  • After-cataract
Shall record the posterior capsule opacification on the 1, 6, 12 month and final time after operation.
  • Fundus
Shall observe the fundus conditions of subject on the 1 week, 1, 6 month and finial time after operation.
  • Intra-ocular pressure
Shall record the intra-ocular pressure on the 1 day, 1 week, 1, 3, 6, 12 month and finial time after operation.
  1. 7.3 Rate of second operation
Shall record the second operation, and its reasons and results.

  

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