Comparison of Corneal Incision Versus Toric Intraocular Lens Techniques Used in Cataract Surgery

August 7, 2024 updated by: Muhammad Naveed Babur, Superior University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

These methods includes limbal relaxing incisions (LRIs) or the insertion of toric IOLs, which are specifically intended to cancel out pre-existing astigmatism and astigmatic keratometry. This research will be conducted to see which method benefits more for treating preoperative astigmatism in eye.

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • Zubaida eyecare center sabzazar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corneal Incision
Diagnostic test: Corneal Incision
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.
Active Comparator: Toric Intraocular
Other: Toric Intraocular
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative visual acuity
Time Frame: 12 Months
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
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall22/734

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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