NCT05014269

Brief Summary

In this retrospective case series, the feasibility of performing phacoemulsification using slit illumination in eyes with corneal opacity was assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

August 9, 2021

Last Update Submit

August 13, 2021

Conditions

Senile Cataract

Keywords

Senile CataractCorneal opacityPhacoemulsification

Outcome Measures

Primary Outcomes (1)

  • The rate of intra-operative complications of phacoemulsification in eyes with corneal opacities using the slit ilumination of the surgical microscope.

    the frequency of the intraoperative complications of phacoemulsification in eyes with corneal opacities

    3 months

Secondary Outcomes (1)

  • Visual outcome of phacoemulsification in eyes with corneal opacities

    3 months

Interventions

Phacoemulsification in eyes with corneal opacitiesPROCEDURE

senile cataract extraction using lens emulsification under the slit illuimnation of the surgical microscope

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with visually significant senile cataract and corneal opacities

You may qualify if:

  • The presence of visually significant senile cataract.
  • A recent history of progressive diminution of vision within few months.
  • Stable density and size of a preexisting trachomatous corneal opacity that does not impair the pupil or lens visualization after pupillary dilatation.

You may not qualify if:

  • History of trauma, infectious corneal ulcers, or intraocular surgery.
  • Coexisting ocular diseases e.g. glaucoma, retinal detachment, and vitreous hemorrhage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Opacity

Interventions

PhacoemulsificationVision, Ocular

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical ProceduresLight Signal TransductionSignal TransductionBiochemical PhenomenaChemical PhenomenaCell Physiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOcular Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ophthalmology

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 20, 2021

Study Start

January 1, 2015

Primary Completion

December 30, 2017

Study Completion

July 31, 2018

Last Updated

August 20, 2021

Record last verified: 2021-08