Indian post marketing data generation among cataract patients using Clareon® IOL with AutonoMe� delivery device

Phase 4

Completed

• Conditions: Health Condition 1: H258- Other age-related cataract

• Registration Number: CTRI/2019/11/022071
• Lead Sponsor: Alcon Laboratories India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-12
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 111

Inclusion Criteria

1. 20 years of age or older at the time of informed consent, of either gender in India, who were diagnosed with age-related unilateral or bilateral cataracts and willing to undergo cataract extraction.

2. Able to comprehend and willing to sign informed consent and complete all required

postoperative follow-up procedures.

3. Calculated lens power between +15.0 and +30.0 D in both eyes.

4. Preoperative or expected postoperative regular corneal astigmatism of < 1.00 D.

Exclusion Criteria

1. Subjects fulfilling any of the following criteria are not eligible for participation in this study:

a. currently pregnant

b. have a positive urine pregnancy test result at screening

c. intend to become pregnant during the study period

d. are currently breast-feeding

Subjects who become pregnant after a study IOL/AutonoMe device has touched the eye will not be discontinued; however, data will be excluded from the effectiveness analyses from that point forward because pregnancy can alter refraction and visual acuity results.

2. Clinically significant corneal abnormalities including corneal dystrophy, corneal degenerations, inflammation, or edema per the Investigatorâ??s expert medical opinion.

3. Previous corneal transplant.

4. Ocular trauma, previous refractive surgery, or refractive procedures throughout the

entire duration of the subjectsâ?? participation in the clinical study (including, but not

limited to LASIK, astigmatic keratotomy, and limbal relaxing incision).

5. History of or concurrent retinal conditions or predisposition to retinal conditions,

diagnosed degenerative eye disorder such as macular degeneration, previous history

of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that

the Investigator judges could confound outcomes. (NOTE: Including but not limited

to background diabetic retinopathy, diabetic macular edema, or proliferative diabetic

retinopathy, macular degeneration).

6. Amblyopia.

7. Rubella, congenital, traumatic, or complicated cataract.

8. Any other conditions (ocular or non-ocular), that may deteriorate the surgical outcome, including but not limited to those in existing literature, based on the Investigatorâ??s expert medical opinion.

9. Diagnosed glaucoma (uncontrolled or controlled with medication).

10. Subjects currently participating in another clinical study.

11. Any current anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction.

12. Iris neovascularization.

13. Extremely shallow anterior chamber, not due to swollen cataract.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of eyes achieving monocular BCDVA of 0.2 logMAR or better in photopic <br/ ><br>conditionsTimepoint: At 1 month post implantation

Secondary Outcome Measures

Name	Time	Method
1. Difference between predicted refraction and manifest refraction <br/ ><br>(spherical equivalent) <br/ ><br>2. Monocular UCDVA in photopic conditions <br/ ><br>3. Monocular BCDVA in photopic conditionsTimepoint: At 1 month post implantation <br/ ><br>