Correction of Refractive Error Surprises After Cataract Surgery in Adults

April 22, 2024 updated by: Abdelrahman Mohamed saad, Assiut University
A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim(s) of the Research:

  1. detection of refractive surprises using autorefractometer, and corneal topography.
  2. treatment of the resulting refractive error surprises.

Study Type

Interventional

Enrollment (Estimated)

63

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

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:

All adult patients scheduled for cataract surgery with:

  • Symptomatizing patients with postoperative spherical error of more than 1 diopters.
  • Symptomatizing patients with postoperative cylindrical error of more than 1 diopters.
  • Symptomatizing patients with uncorrected distant visual acuity less than 6/24
  • Symptomatizing patients with corrected distant visual acuity of less than 6/12
  • Clear cornea. 6. Uneventful surgery.

Exclusion Criteria:

  • Patients with complicated cataract.
  • Raised intraocular pressure (IOP).
  • Patients with pathologies of the posterior segment of the eye.
  • Other causes of diminution of vision.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corneal refractive surgery
Among patients scheduled for cataract surgery, Group I; will undergo Corneal refractive surgery to correct any post-operative refractive surprises.
Procedure: Refractive surgeries
after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options
Active Comparator: IOL exchange
Among patients scheduled for cataract surgery, Group II; will undergo IOL exchange to correct any post-operative refractive surprises.
Procedure: Refractive surgeries
after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options
Active Comparator: Piggyback sulcus IOL
Among patients scheduled for cataract surgery, Group III; will undergo Piggyback sulcus IOL to correct any post-operative refractive surprises.
Procedure: Refractive surgeries
after primary phacoemulsification surgery any resulting refractive error surprises will be corrected with different refractive surgery options

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis and treatment of the resulting refractive error surprises
Time Frame: Baseline
Rate of refractive error surprises
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Magdy M Mostafa, MD, Assiut University
  • Study Director: Mohamed S Hussien, MD, Assiut University
  • Study Director: Ali N Ryad, MD, Assiut University

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

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • refractive error surprises

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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