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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04140383
Other study ID # Sakarya Ophthalmology
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2, 2017
Est. completion date February 25, 2018

Study information

Verified date October 2019
Source Sakarya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

The medical records of patients who were underwent cataract surgery between January 2014 and October 2017 were investigated retrospectively and patients 65 years and older were recruited. Two groups were made according to age: group1 composed of patients age range between 65 and 85 years and group 2 composed of patients 85 years and older. Gender, presence of diabetes mellitus (DM), hypertension (HT), drug use were noted.

The results of best corrected visual acuity (BCVA) converted to LogMar, intraocular pressure (IOP) before and 3 months after operation, biomicroscopic and fundus examinations were investigated.

Additional ocular diseases such as glaucoma, age related macular degeneration (AMD), pseudoexfoliation syndrome, retinopathies and maculopathies related to systemic diseases were noted. Pupil dilation properties were also noted as poor, mid or full pupil dilation.

Cataract surgery techniques such as phacoemulsification, extra- and intracapsular lens extractions, peroperative complications, intracameral drug use were investigated.

these aforementioned outcomes evaluated and compared between groups.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date February 25, 2018
Est. primary completion date December 2, 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years to 95 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- patients aged below 65 years who underwent cataract surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cataract Surgery
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.

Locations

Country Name City State
Turkey Sakarya University Ophthalmology Department Sakarya

Sponsors (1)

Lead Sponsor Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Best corrected visual acuity Best corrected visual acuity converted to LogMar Before cataract surgery
Primary Best corrected visual acuity Best corrected visual acuity converted to LogMar three months after cataract surgery
Secondary presence of Diabetes Mellitus number of participants who have diabetes mellitus Baseline (Before cataract surgery)
Secondary presence of essential hypertension number of participants who have essential hypertension before cataract surgery
Secondary oral acetylsalicylic acid use number of participants who have a history of acetylsalicylic acid use before cataract surgery
Secondary oral flomax use number of participants who have a history of oral flomax use before cataract surgery
Secondary presence of age related macular degeneration number of participants who have age related macular degeneration Baseline (Before cataract surgery)
Secondary presence of glaucoma number of participants who have glaucoma before cataract surgery
Secondary presence of pseudoexfoliation number of participants who have pseudoexfoliation before cataract surgery
Secondary presence of poor pupil dilation number of participants who have poor pupil dilation During cataract surgery
Secondary presence of zonule deficiency number of participants who have zonule deficiency During cataract surgery
Secondary Cataract types in patients who underwent cataract surgery number of participants who have nuclear, posterior subcapsular, corticonuclear, mature, nigra, traumatic cataract Baseline (Before cataract surgery)
Secondary measurement of effective phacoemulsification time measurement of effective phacoemulsification time in participants who underwent cataract surgery During cataract surgery
Secondary presence of posterior capsule rupture participants who had posterior capsule rupture during surgery During cataract surgery
Secondary anterior vitrectomy number of participants who needed anterior vitrectomy during cataract surgery during surgery
Secondary presence of aphakia number of participants who left aphakic after cataract surgery 3 months after cataract surgery
Secondary intracameral adrenalin use number of participants who needed intracameral adrenalin use during surgery
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