NCT04140383

Brief Summary

This study evaluates and compares clinical outcomes of \< 85 and ≥ 85 year old patients who underwent cataract surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

October 13, 2019

Last Update Submit

October 24, 2019

Conditions

Keywords

geriatrycataract surgeryadvanced age

Outcome Measures

Primary Outcomes (2)

  • Best corrected visual acuity

    Best corrected visual acuity converted to LogMar

    Before cataract surgery

  • Best corrected visual acuity

    Best corrected visual acuity converted to LogMar

    three months after cataract surgery

Secondary Outcomes (15)

  • presence of Diabetes Mellitus

    Baseline (Before cataract surgery)

  • presence of essential hypertension

    before cataract surgery

  • oral acetylsalicylic acid use

    before cataract surgery

  • oral flomax use

    before cataract surgery

  • presence of age related macular degeneration

    Baseline (Before cataract surgery)

  • +10 more secondary outcomes

Study Arms (2)

Group 1, patients aged 85 years and older

75 eyes of 75 patients (39 female, 36 male) Mean age: 86,8 ± 1,8 years

Procedure: Cataract Surgery

Group 2, patients aged 65 and 85 years

77 eyes of 77 patients (34 female, 43 male) Mean age:73,3 ± 5,2 years

Procedure: Cataract Surgery

Interventions

Cataract surgery was performed by using phacoemulsification technique, routinely. But other techniques for instance extra or intracapsular cataract extraction (ECCE, ICCE) techniques were performed when needed. Phacoemulsification technique was performed by 2 experienced surgeon (G.A. and E.C.) under topical anesthesia, thorough limbal incision. Foldable single piece hydrophobic acrylic intraocular lens (IOL) was inserted in the bag. In the presence of complications related to anterior or posterior capsules, 3 pieces IOL was preferred. When ECCE technique was chosen, single piece polymethyl methacrylate IOL was inserted.

Group 1, patients aged 85 years and olderGroup 2, patients aged 65 and 85 years

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients aged 65 years and older who underwent cataract surgery

You may qualify if:

  • patients aged 65 years and older patients who underwent cataract surgery

You may not qualify if:

  • patients aged below 65 years who underwent cataract surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Ophthalmology Department

Sakarya, Turkey (Türkiye)

Location

Related Publications (1)

  • Syam PP, Eleftheriadis H, Casswell AG, Brittain GP, McLeod BK, Liu CS. Clinical outcome following cataract surgery in very elderly patients. Eye (Lond). 2004 Jan;18(1):59-62. doi: 10.1038/sj.eye.6700521.

Related Links

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Burcin Cakir, MD

    Sakarya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 13, 2019

First Posted

October 25, 2019

Study Start

October 2, 2017

Primary Completion

December 2, 2017

Study Completion

February 25, 2018

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report Access

Locations