This is a comparative clinical trial of two phakic toric lens in patient with Near-sightedness and cylindrical refractive error.

Phase 4

• Conditions: Health Condition 1: H521- Myopia

• Registration Number: CTRI/2021/12/038930
• Lead Sponsor: Biotech Healthcare Holdings GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients 21 years old or older.

2. Calculated IOL Power is within the range of the investigational IOLs

3. Corneal Cylindrical error within the range defined in the clinical investigation plan

4. Subject has monocular UCVA 0.5 LogMAR or worse

5. Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.

6. Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria:

a. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.

b. Two refractions were performed at least 7 days apart.

7. Subject, who is expected to have residual postoperative cylindrical refractive error of >=1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.

8. Expected dilated pupil size at least large enough to visualize the axis marking.

9. Patients willing to attend all follow-up appointments

10. Patients must sign and be given a copy of the written Informed Consent form

11. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.

Exclusion Criteria

1. Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.

2. Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject

3. Subject with ocular condition that may predispose the subject to future complications

4. Subject with previous intraocular or corneal surgery

5. Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment

6. Pregnant or planning to become pregnant, or is lactating during the course of the evaluation

7. Other condition associated with fluctuation of hormones

8. ACD measured from the endothelium lower than 2.8 mm

9. Concurrent participation in another drug or device evaluation.

10. Any cataract of any grade

11. Coefficient of variation of endothelial cell area >0.45

12. Percent Hexagonality of endothelial cell shape <= 45%

13. Monocular subject

14. Vulnerable subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified