NCT06548308

Brief Summary

Eyesight and quality of life improves in patients after refractive cataract surgery because this surgery treats myopia, hyperopia and presbyopia except astigmatism. In order to make a patient spectacle free Ophthalmologists use different methods during cataract surgery to minimize astigmatism.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

3.5 years

First QC Date

August 7, 2024

Last Update Submit

August 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • postoperative visual acuity

    The postoperative visual acuity and refractive outcomes between patients undergoing cataract surgery with corneal incision and those with toric IOL implantation.

    12 Months

  • effectiveness of astigmatism correction

    Investigate the effectiveness of astigmatism correction achieved by both toric iol and corneal inscion technique and determine the degree of residual astigmatism in both groups after followups .

    12 months

Study Arms (2)

Corneal Incision

EXPERIMENTAL
Diagnostic Test: Corneal Incision

Toric Intraocular

ACTIVE COMPARATOR
Other: Toric Intraocular

Interventions

Corneal IncisionDIAGNOSTIC_TEST

Astigmatism will be assessed by objective and subjective refraction by using the Autorefrectometer and retinoscop.Autorefrectometer uses to acsess the refracive state of eye by which we measure the astigmatim in patients eyes .Then after ctaract surgry in the next followup we will again use autorefrectometer to take readings and these both will be compared on visits among patients undergoing two procedures.

Corneal Incision

Two cataract surgery techniques will be used .1 : Toric IOL lenses designed with a unique shape to help provide clear vision at all distances for individuals with astigmatism compared to give better results specially in astigmatic patients.2: Corneal Inscion is which eye surgeon makes a very small opening on the eye, next to the outer corner. to remove the catract during surgry .

Toric Intraocular

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders were included.
  • Patients having astigmatism was included. Patients having cataract was included.
  • Eyes having no other ocular pathology was included.
  • Patients having no history of corneal scar was included

You may not qualify if:

  • Eyes having any ocular pathology will be excluded.
  • Patients with corneal suture will be excluded.
  • Those using contact lenses instead of spectacles for vision correction will be excluded.
  • Participants with a history of eye surgery within the past year will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zubaida eyecare center sabzazar

Lahore, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 12, 2024

Study Start

October 1, 2020

Primary Completion

April 1, 2024

Study Completion

September 30, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations