Correction of Refractive Error Surprises After Cataract Surgery in Adults

Not Applicable

Not yet recruiting

• Conditions: Refractive Errors
• Interventions: Procedure: Refractive surgeries

• Registration Number: NCT06379477
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-03-22
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-22
• Last Update Submitted: 2024-04-22
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Study Start: 2024-06-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corneal refractive surgery	Refractive surgeries	Among patients scheduled for cataract surgery, Group I; will undergo Corneal refractive surgery to correct any post-operative refractive surprises.
IOL exchange	Refractive surgeries	Among patients scheduled for cataract surgery, Group II; will undergo IOL exchange to correct any post-operative refractive surprises.
Piggyback sulcus IOL	Refractive surgeries	Among patients scheduled for cataract surgery, Group III; will undergo Piggyback sulcus IOL to correct any post-operative refractive surprises.

Primary Outcome Measures

Name	Time	Method
Diagnosis and treatment of the resulting refractive error surprises	Baseline	Rate of refractive error surprises