Skip to main content
Clinical Trials/CTRI/2024/08/071812
CTRI/2024/08/071812RecruitingPhase 4

A Prospective Comparative randomized post marketing clinical study to assess and compare the visual performance and safety of two different trifocal Intraocular lens following bilateral implantation

Biotech vision care pvt ltd1 site in 1 country216 target enrollmentStarted: September 5, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
216
Locations
1
Primary Endpoint
Uncorrected Intermediate Visual Acuity (UIVA) (Photopic)

Study Overview

Brief Summary

Presbyopia is one of the most common causes of vision impairment, affecting an estimated 2 billion people, globally.1 Presbyopia has been associated with negative impacts on quality of life in people aged 40 and above from developing and developed nations alike because it causes difficulties with reading and with accomplishing near vision tasks. Non-invasive methods of correcting presbyopia have been used for many years. While bifocal or multifocal progressive addition lenses, monofocal or bifocal contact lenses can provide satisfactory distance and near vision to presbyopes without the potential risks of a surgical procedure, they cannot restore or substitute the true process of accommodation of a younger individual. Among the surgical options, presbyopia correction can be achieved with excimer or femtosecond laser ablation on cornea (LASIK, PRK, Presbylasik, Supracor, Intracor, etc.), Another recent corneal approach is the insertion of inlays, both artificial and made of corneal tissue in order to change the central curvature of the cornea. Lens extraction with implantation of multifocal, monofocal (monovision) or accommodative intraocular lenses is another method for correction of presbyopia, and has started to become the preferred method for presbyopic correction, particularly in a cataract-aged population. Increasingly, trifocal IOLs – offering correction for near, intermediate and distance vision – are more frequently used.

Purpose:

To evaluate and compare the visual performance of two different trifocal intraocular lens in terms of quality of vision and verify the safety profile

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Adult patient, 18 years old or older will be enrolled in the study
  • Patient with cataract
  • Calculated IOL power is within the range of the study IOL
  • Patients must sign and be given a copy of the written Informed Consent form
  • Clear intraocular media other than cataract
  • Patient willing to undergo the investigations and comply with the follow-up schedule
  • 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

  • Previous intraocular or corneal surgery
  • Traumatic cataract
  • Pregnancy or lactation
  • Concurrent participation in another drug or device investigation
  • Instability of keratometry or biometry measurements
  • Irregular astigmatism
  • More than 1 D of pre-operative corneal astigmatism.

Outcomes

Primary Outcomes

Uncorrected Intermediate Visual Acuity (UIVA) (Photopic)

Time Frame: Measured at Time frame: | Monocular | Post-operative: 120-180 days, 330-420 days | Binocular: Post-operative 330-420 days]

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Biotech vision care pvt ltd
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Shreyas Ramamurthy

The Eye Foundation

Study Sites (1)

Loading locations...

Similar Trials

Assessment of visual outcomes of a new... | Clinical Trial