Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery

Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery: a Prospective Cohort Study

Globally, cataract is the major cause of blindness accounting for 51% of total blindness and there are regional variations in it. Today, cataract surgery is a highly successful and cost-effective procedure, which enhances both the vision and quality of life of patients.

Visual acuity alone should not be used as a criterion for planning cataract surgery, since visual acuity and function do not necessarily correlate. Therefore, there is a need to review our criteria for management.

Based on recent studies, at least 90% of the patients undergoing cataract surgery obtain a postoperative visual acuity of 6/12 or better in the absence of coexisting ocular pathology.

A number of previous studies have looked at the effect of risk factors on visual outcomes following cataract surgery. Risk factors commonly associated with worse visual outcomes include: age-related macular degeneration, diabetic retinopathy, corneal opacity/pathology, older age, female sex, previous vitrectomy, previous retinal detachment surgery, alpha-blockers, complex surgery, intraoperative complications and refractive surprise.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Procedure: Phacoemulsification

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients for cataract surgery received a comprehensive ophthalmic examination. The standard pre-operative examination included a detailed history, measurements of presenting visual acuity

Description

Inclusion Criteria:

• Patients with any type of cataract.

Exclusion Criteria:

• Patients with diabetic retinopathy.
• Patients with previous ocular surgeries or pathologies.
• Patients with pre-operative visual acuity (no perception of light)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lens Phacoemulsification Group; insertion of intra-ocular lens	Procedure: Phacoemulsification; insertion of intra-ocular lens after emulsification of catractous lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The visual acuity of patients after cataract surgery	measured by snellen's chart	4 weeks

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: UECS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No