Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000763246
Ethics application status
Approved
Date submitted
20/04/2018
Date registered
7/05/2018
Date last updated
7/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The evaluation of cataract surgery effects on the retinal layer thickness in cataract patients.
Scientific title
The effects of uncomplicated cataract surgery on the retinal layer thickness in cataract patients.
Secondary ID [1] 294665 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 307522 0
Condition category
Condition code
Eye 306597 306597 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cataract surgery was performed with the Infiniti phacoemulsification device. After surgery, the changes of retinal layer thicknesses were evaluated by spectral domain optical coherence tomography. The image acquisition was followed by automatic intra-retinal layer segmentation performed by the inbuilt Spectralis software. Intra-retinal layer thicknesses were obtained for each Early Treatment Diabetic Retinopathy Study subfield at a central 1 mm circle and 1-3 mm circles. The cataract surgery would be performed regardless of whether the participants are enrolled in the study. Data were collected preoperatively, and on postoperative day 1, 7 (first week), 30 (first month), 90 (third month) and 180 (sixth month).
Intervention code [1] 300964 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305599 0
The primary outcome was to evaluate of the retinal layer thickness changes after cataract surgery. The retinal layer thicknesses were measured quantitatively by Spectral Domain optical coherence tomography before and after uncomplicated cataract surgery.
Timepoint [1] 305599 0
Timepoint: Baseline (on the day before surgery), and on postoperative day 1, 7 (first week - primary endpoint), 30 (first month), 90 (third month) and 180 (sixth month).
Secondary outcome [1] 345850 0
Total energy taken to provide effect phacoemulsification

Total energy taken was assessed used with phacoemulsification device records .
Timepoint [1] 345850 0
Timepoint: Baseline (on the day before surgery), and on postoperative day 1, 7 (first week), 30 (first month), 90 (third month) and 180 (sixth month).
Secondary outcome [2] 346398 0
Time take to provide effective phacoemulsification

Time taken was assessed used with phacoemulsification device records .
Timepoint [2] 346398 0
Timepoint: Baseline (on the day before surgery), and on postoperative day 1, 7 (first week), 30 (first month), 90 (third month) and 180 (sixth month).

Eligibility
Key inclusion criteria
Patients undergoing phacoemulsification surgery with intraocular lens implantation.
Be at least 45 years old, male or female.
Willing to measure retinal layer thickness before and after cataract surgery.
Minimum age
48 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
macular pathologies, retinal vascular occlusion, history of any other ocular disorder (including uveitis, severe dry eye, eye trauma, glaucoma, pseudoexfoliation syndrome) or surgery, any systemic disorder (such as diabetes, hypertension, asthma or chronic obstructive pulmonary disease), systemic inflammation (inflammatory bowel disease, hepatitis B or C), the current use of any topical or systemic medication or anti-inflammatory agent, intraoperative complications such as posterior capsular rupture, vitreous loss, iris prolapse and low scan quality images due to dense cataract.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The IBM SPSS version 20.0 (IBM Corporation, Armonk, NY, USA) software was used for statistical analyses. Measured data were described as the arithmetic mean ± standard deviation, whereas categorical data were described as percentages (%). Normal distribution of measured data was examined by the Kolmogorov-Smirnov test. The one-way ANOVA test was used for inter-group comparison variables for repeated measures. The Bonferroni method was used to correct the p value. The relationship between effective phaco time and total energy and all thickness parameters was analyzed with Pearson correlation analysis. A statistical level of significance was accepted at p<0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
19/12/2016
Date of last participant enrolment
Anticipated
Actual
6/04/2017
Date of last data collection
Anticipated
Actual
10/10/2017
Sample size
Target
43
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 10340 0
Turkey
State/province [1] 10340 0
Kirsehir

Funding & Sponsors
Funding source category [1] 299278 0
Hospital
Name [1] 299278 0
Ahi Evran University Training and Research Hospital
Country [1] 299278 0
Turkey
Primary sponsor type
Hospital
Name
Ahi Evran University Training and Research Hospital
Address
Ahi Evran University Training and Research Hospital, Kervansaray district, 2019.street, No:1, Kirsehir, 40200,Turkey.
Country
Turkey
Secondary sponsor category [1] 298548 0
None
Name [1] 298548 0
Address [1] 298548 0
Country [1] 298548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300190 0
Ethical Committe of Ankara Numune Training and Research Hospital
Ethics committee address [1] 300190 0
Ankara Numune Training and Research Hospital
Talatpasa Avenue no:5 Altindag/Ankara
Ethics committee country [1] 300190 0
Turkey
Date submitted for ethics approval [1] 300190 0
01/12/2016
Approval date [1] 300190 0
14/12/2016
Ethics approval number [1] 300190 0
1113/2016

Summary
Brief summary
Purpose: Our aim was to assess changes in the total retinal thickness (TRT), total retinal volume (TRV) and retinal layer thickness after uncomplicated cataract surgery.
Methods: A total of 32 eyes of 32 patients who had undergone uncomplicated phacoemulsification surgery and intraocular lens implantation in one eye were enrolled. Effective phacoemulsification time (EPT) and total energy (TE) were recorded. Thickness and TRV were measured using optical coherence tomography. Data were collected preoperatively and at postoperative day 1, 7, 30, 90 and 180.
Results: The study results showed a decrease in TRT, TRV and most retinal layer thicknesses at the first postoperative day visit, then increasing at week 1, month 1 and 3, and then relatively decreasing at month 6 although not returning to preoperative levels. The least affected layers were the retinal pigment epithelium and outer plexiform layer. There was a positive correlation between EPT and TE and ganglion cell layer in a 1 mm circle and inner nuclear layer in a 1-3 mm circle (p<0.05).
Conclusion: The results suggest that long-term follow-up of more than 6 months is necessary after cataract surgery to see if total retinal and segmental values return to preoperative levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82854 0
Dr Ali Kurt
Address 82854 0
Ahi Evran University Training and Research Hospital, Kervansaray district, 2019.street, No:1, Kirsehir, 40200,Turkey.
Country 82854 0
Turkey
Phone 82854 0
+90 537 0275488
Fax 82854 0
Email 82854 0
[email protected]
Contact person for public queries
Name 82855 0
Dr Ali Kurt
Address 82855 0
Ahi Evran University Training and Research Hospital, Kervansaray district, 2019.street, No:1, Kirsehir, 40200,Turkey.
Country 82855 0
Turkey
Phone 82855 0
+90 537 0275488
Fax 82855 0
Email 82855 0
[email protected]
Contact person for scientific queries
Name 82856 0
Dr Ali Kurt
Address 82856 0
Ahi Evran University Training and Research Hospital, Kervansaray district, 2019.street, No:1, Kirsehir, 40200,Turkey.
Country 82856 0
Turkey
Phone 82856 0
+90 537 0275488
Fax 82856 0
Email 82856 0
[email protected]

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