Effect of Single Incision Versus Three Planned Incisions to Reduce Pre-operative Astigmatism After Phacoemulsification.

July 11, 2022 updated by: Jamshad Ahmed, Suleman Roshan Medical College

Effect of Single Incision Versus Three Planned Incision to Reduce Pre-operative Astigmatism After Phacoemulsification.

Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a monofocal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism4. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

According to the 2020 estimate, 33·6 million adults aged 50 years and older were blind with cataracts as a leading cause (15·2 million cases). According to Pakistan national blindness survey, cataract is the leading cause of blindness in Pakistan. Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a mono-focal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide). Our study aims to compare the results of phacoemulsification cataract surgery with a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) with convention supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism. We hypothesize that a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) is better than conventional supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism at a significant level of 0.05.

Study Type

Interventional

Enrollment (Anticipated)

160

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 Contact

Study Locations

  • Pakistan
    • Sindh
      • Tando Adam, Sindh, Pakistan, 68050
        • Suleman Roshan Medical College Hospital
        • Contact:
          • Jamshad Ahmed, FCPS
          • Phone Number: 03332441746

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Cataract patients aged between 50 and 80 years having 1.0 diopters (D) or greater of regular corneal astigmatism documented by keratometry.

Exclusion Criteria:

1. Previous ocular surgery. 2. previous ocular trauma. 3. Pre-existing ocular disease. 4. High intraocular pressure (IOP) 5. Corneal opacity. 6. Strabismus 7. Amblyopia 8. Diabetes mellitus 9. Irregular astigmatism.

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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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A:experimental group
those who receive planned incisions
Procedure: Planned incisions during phacoemulsification
Planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian will be performed in the experimental group during phacoemulsification
Active Comparator: Group B:Controlled group
the patients who were operated by conventional phacoemulsification
Procedure: Planned incisions during phacoemulsification
Planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian will be performed in the experimental group during phacoemulsification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Astigmatism
Time Frame: Patients will be assessed at first postoperative day then after one month , three months and six months.
Postoperative reduction in astigmatism after phacoemulsification.
Patients will be assessed at first postoperative day then after one month , three months and six months.

Collaborators and Investigators

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

Sponsor

Suleman Roshan Medical College

Investigators

  • Principal Investigator: Jamshad Ahmed, FCPS, Suleman Roshan Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Anticipated)

July 30, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

March 2, 2023

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Corneal incision & Astigmatism

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the clinical study report will be shared with all participants if they desire. the study will be published in a journal. it will be available to all participants and the research community.

IPD Sharing Time Frame

after 6 months

IPD Sharing Access Criteria

contact with principal investigator

IPD Sharing Supporting Information Type

  • CSR

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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