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Clinical Trials/CTRI/2024/06/068809
CTRI/2024/06/068809CompletedNot Applicable

Comparison Of Clinical Outcomes Of Computer Assisted And Smartphone Based Target Axis Alignment For Toric Intra Ocular Lens Implantation

Dr Arya S S1 site in 1 country90 target enrollmentStarted: July 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
To measure angular deviation IOL alignment of computer aided axis mark from the target axis vs angular deviation of IOL alignment of smartphone-assisted mark from the target axis, compare the best corrected visual acuity and postoperative residual astigmatism

Study Overview

Brief Summary

This is an Observational randomized parallel group trial to study and compare the clinical outcomes of Computer assisted and Smartphone based target axis marking for the implantation of a toric intra ocular lens during cataract surgery for patients with regular corneal astigmatism of more than 1.2 DCYL, which will be conducted at Base hospital, Department of Ophthalmology ( teritiary care hospital ) in India. The primary outcome is to measure the final axis deviation of Toric IOL from the calculated axis with the above said methods of axis marking. The secondary outcome is to measure and compare the best corrected visual acuity and postoperative residual astigmatism in both cases.

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

  • 1.All patients above 18 years and below 80 years 2.Diagnosed with cataract and planned to undergo phacoemulsification and toric monofocal IOL implantation.
  • 3.Patients having regular corneal astigmatism of more than 1.2 and axial length between 22mm and 23.5mm.

Exclusion Criteria

  • 1.Irregular corneal astigmatism 2.Previous intraocular or corneal surgeries 3.Intraoperative complications compromising toric IOL position such as zonular damage, vitreous loss, capsulorrhexis tear, posterior capsular rupture or any condition which could interfere with the visual outcome 4.Those with the postoperative findings of high myopia, glaucoma, retinal disease, postoperative miosis, prolonged postoperative iritis, etc.

Outcomes

Primary Outcomes

To measure angular deviation IOL alignment of computer aided axis mark from the target axis vs angular deviation of IOL alignment of smartphone-assisted mark from the target axis, compare the best corrected visual acuity and postoperative residual astigmatism

Time Frame: Postop day 1, 7 and 30

Secondary Outcomes

  • comparison of best corrected visual acuity (BCVA) and postoperative residual astigmatism.(Postop day 1, 7 and 30)

Investigators

Sponsor
Dr Arya S S
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Arya S S

Base Hospital, Delhi Cantt

Study Sites (1)

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