NCT03593616

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

July 11, 2018

Last Update Submit

July 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The visual acuity of patients after cataract surgery

    measured by snellen's chart

    4 weeks

Study Arms (1)

Lens Phacoemulsification Group

insertion of intra-ocular lens

Procedure: Phacoemulsification

Interventions

insertion of intra-ocular lens after emulsification of catractous lens

Lens Phacoemulsification Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients with any type of cataract.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 20, 2018

Study Start

September 1, 2018

Primary Completion

August 1, 2019

Study Completion

November 1, 2019

Last Updated

July 20, 2018

Record last verified: 2018-07