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Clinical Trials/CTRI/2023/12/060492
CTRI/2023/12/060492
Not yet recruiting
Phase 3

Comparison of clinical outcomes and patient satisfaction of two Hydrophobic EDOF Toric intraocular lenses following bilateral implantation. - NI

Biotech Vision Care Pvt Ltd Ahmedabad India0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: H259- Unspecified age-related cataract

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: H259- Unspecified age-related cataract
Sponsor
Biotech Vision Care Pvt Ltd Ahmedabad India
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Biotech Vision Care Pvt Ltd Ahmedabad India

Eligibility Criteria

Inclusion Criteria

  • •1\. Cataractous lens changes as demonstrated by best corrected
  • •visual acuity of 20/40 or worse either with or without a glare
  • •source present (e.g., Brightness Acuity Tester) or with significant
  • •cataract\-related visual symptoms.
  • •2\. Best corrected visual acuity to be better than 20/30 after cataract
  • •removal and IOL implantation as estimated by potential acuity
  • •meter (PAM) or surgeon estimation
  • •3\. Clear intraocular media other than cataract.
  • •4\. Given written informed consent by subject.
  • •5\. Subjects are willing and able to comply with schedule for follow up visits.

Exclusion Criteria

  • •1\. Systemic disease that could increase the operative risk or
  • •confound the outcome.
  • •2\. Systemic medications that may confound the outcome or increase
  • •the risk to the subject in the opinion of the investigator
  • •(tamsulosin hydrochloride (Flomax) or other medications with
  • •similar side effects (floppy iris syndrome)).
  • •3\. Ocular condition that may predispose for future complications.
  • •4\. Previous intraocular or corneal surgery that might confound the
  • •outcome of the investigation or increase the risk to the subject.

Outcomes

Primary Outcomes

Not specified

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