Pupillary DisordersNCT04286646
Correlation of Pupillary Diameter Changewith Age and Anterior Chamber Depth After Cataract Surgery
An observational study of Pupillary Disorders, run by Clinica Oftalmologica TACIR at 1 site in Spain.
Trial summary
PURPOSE: To assess the correlation between the change in pupil diameter, age and depth of the anterior chamber after 3 months of cataract surgery both in photopic and mesopic conditions. And study the changes of the pupillary diameter at 3 months after surgery in the two light conditions Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Pupillary Disorders
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2018to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The field in which the study will be carried out is a private medical centre. TACIR Ophthalmology clinic is located in the TEKNON Medical Center in the city of Barcelona. The study population will be the patients of the TACIR ophthalmology clinic who will be operated on cataracts and agree to take part in the study.
Who may be able to join
- Both sexes with age equal to or greater than 45 years
- Diagnosed cataract N1, C1, P1 or worse in some eye.
- Patients who will be operated on both eyes.
- Patients who have not been diagnosed with diabetes mellitus.
- Patients who have given their informed consent to take part in the study.
Who cannot join
- Age under 45 years.
- Patients with anisocoria, neurological disorders, diagnosed with diabetes mellitus, glaucoma or another eye disease.
- Patients with complications during and after cataract surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Pupillary Diameter Change With Age and Anterior Chamber Depth After Cataract Surgery
PURPOSE: To assess the correlation between the change in pupil diameter, age and depth of the anterior chamber after 3 months of cataract surgery both in photopic and mesopic conditions. And study the changes of the pupillary diameter at 3 months after surgery in the two light conditions
Read the detailed description
Healthy patients who are going to be operated on for cataracts are expected to take part in the study. If during the clinical study the minimum number of patients established in the protocol is exceeded, new samples will continue to be registered until the end of the established period.
The sample selection mechanism is by consecutive recruitment during the study period (in order of arrival at the medical office). Patients are operated bilaterally in a period not exceeding 15 days and it will get the variables of both eyes. A simple random sampling will be used for the choice of single eye data per patient.
- Conditions
- Pupillary Disorders
- Keywords
- Cataract, Pupillary changes, Age, Anterior chamber depth
- Medical subject headings
- Pupil Disorders, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pupil diameter before/after cataract | The investigators measure the pupil diameter before and after (3 months) cataract. Mesopic and photopic conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil diameter
It took measurements of pupil diameter in mesopic and photopic conditions using pupillometer software of the Topolyzer Vario (Wavelight Laser Technologie AG).
Measured: Preoperatively and 3-months postoperatively
Anterior Chamber Depht
Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
Measured: Preoperatively
Age
It took the patient's age at the time of surgery
Measured: Preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start20 May 2018
- Primary completion21 Jun 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pupillary DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Oftalmologica TACIR
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Ordiñaga-Monreal, OD, MSc, Clinica Oftalmologica TACIR
- Investigators
- Enrique Ordiñaga-Monreal, OD, Principal investigator, Clinica Oftalmologica TACIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286646
- Sponsor's protocol ID
- EC022018
- Other IDs
- 47/2018
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kanellopoulos AJ, Asimellis G, Georgiadou S. Digital pupillometry and centroid shift changes after cataract surgery. J Cataract Refract Surg. 2015 Feb;41(2):408-14. doi: 10.1016/j.jcrs.2014.05.049.
PubMed 25661135Ordinaga-Monreal E, Castanera-Gratacos D, Castanera F, Fambuena-Muedra I, Vega F, Millan MS. Pupil size differences between female and male patients after cataract surgery. J Optom. 2022 Apr-Jun;15(2):179-185. doi: 10.1016/j.optom.2020.09.005. Epub 2021 Feb 3.
PubMed 33549502
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Pupillary Diameter Change With Age and Anterior Chamber Depth After Cataract Surgery
- ClinicalTrials.gov ID
- NCT04286646
- Acronym / sponsor ID
- EC022018
- Conditions
- Pupillary Disorders
- Keywords
- Cataract, Pupillary changes, Age, Anterior chamber depth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Clinica Oftalmologica TACIRUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE: To assess the correlation between the change in pupil diameter, age and depth of the anterior chamber after 3 months of cataract surgery both in photopic and mesopic conditions. And study the changes of the pupillary diameter at 3 months after surgery in the two light conditions
Detailed description
Healthy patients who are going to be operated on for cataracts are expected to take part in the study. If during the clinical study the minimum number of patients established in the protocol is exceeded, new samples will continue to be registered until the end of the established period.
The sample selection mechanism is by consecutive recruitment during the study period (in order of arrival at the medical office). Patients are operated bilaterally in a period not exceeding 15 days and it will get the variables of both eyes. A simple random sampling will be used for the choice of single eye data per patient.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pupil diameter before/after cataract | – | –The investigators measure the pupil diameter before and after (3 months) cataract. Mesopic and photopic conditions |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The field in which the study will be carried out is a private medical centre. TACIR Ophthalmology clinic is located in the TEKNON Medical Center in the city of Barcelona. The study population will be the patients of the TACIR ophthalmology clinic who will be operated on cataracts and agree to take part in the study.
Key inclusion criteria (5 listed)
- Both sexes with age equal to or greater than 45 years
- Diagnosed cataract N1, C1, P1 or worse in some eye.
- Patients who will be operated on both eyes.
- Patients who have not been diagnosed with diabetes mellitus.
- Patients who have given their informed consent to take part in the study.
Key exclusion criteria (3 listed)
- Age under 45 years.
- Patients with anisocoria, neurological disorders, diagnosed with diabetes mellitus, glaucoma or another eye disease.
- Patients with complications during and after cataract surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pupil diameter
Time frame: Preoperatively and 3-months postoperatively
It took measurements of pupil diameter in mesopic and photopic conditions using pupillometer software of the Topolyzer Vario (Wavelight Laser Technologie AG).
Anterior Chamber Depht
Time frame: Preoperatively
Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
Age
Time frame: Preoperatively
It took the patient's age at the time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Background: PubMed 25661135Kanellopoulos AJ, Asimellis G, Georgiadou S. Digital pupillometry and centroid shift changes after cataract surgery. J Cataract Refract Surg. 2015 Feb;41(2):408-14. doi: 10.1016/j.jcrs.2014.05.049.
- Derived from this study: PubMed 33549502Ordinaga-Monreal E, Castanera-Gratacos D, Castanera F, Fambuena-Muedra I, Vega F, Millan MS. Pupil size differences between female and male patients after cataract surgery. J Optom. 2022 Apr-Jun;15(2):179-185. doi: 10.1016/j.optom.2020.09.005. Epub 2021 Feb 3.
- Individual participant dataSharing planned: No
Related trials for Pupillary Disorders
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Not yet recruitingObservational study
Oculomotor-Pupillary AI Biomarkers in Parkinson's
PARKINSON DISEASE (Disorder)
RecruitingObservational study
Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
Hypotension, Spinal Anesthesia
RecruitingObservational study
A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
Neurotoxicity
Active, not recruitingObservational study
Anisocoria in the Intensive Care Unit (AICU Study)
Anisocoria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Ordiñaga-Monreal, OD principal investigator
Clinica Oftalmologica TACIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pupillary Disorders, run by Clinica Oftalmologica TACIR at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil diameter (time frame: Preoperatively and 3-months postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286646, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.