PseudoexfoliationNCT04965168
Corneal Endothelium Evaluation After Phacoemulsification in Diabetec and Non-diabetic Patients With Pseudoexfoliation
A study testing phacoemulsification of the lens in people with Pseudoexfoliation, run by Minia University at 1 site in Egypt.
Trial summary
Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pseudoexfoliation
- What is being tested?
- phacoemulsification of the lens
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 16 Oct 2021
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Senile cataract with age between 50 to 70 years
- Clear cornea with no zonuler dehiscence
- Lens opacity classification system III (LOCS III), with grade 2-3 nuclear cataract with any additional cortical (C) and posterior sub capsular (P)
Who cannot join
- Uncontrolled DM in diabetic groups
- Presence of autoimmune diseases
- Patients with glaucoma
- Corneal guttata
- Zonular dehiscence
- Rupture posterior capsule during cataract surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ophthalmology department/ Minia University Hospital/Minia University
Minya, 61111
About this study
Official title: Evaluation of Corneal Endothelium Following Phacoemulsification in Diabetic and Non-diabetic Patients With Pseudoexfoliation Syndrome by Specular Microscopy
Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using specular microscopy.
Read the detailed description
Our study is a comparative study that included 4 groups (controls, patients with PEX, non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over a 6 months follow up period.
- Conditions
- Pseudoexfoliation
- Being tested
- phacoemulsification of the lens
- Keywords
- DM, phacoemulsification, endothelial cell density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification of the lensProcedure or surgery
all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
| Study group | Role | What they receive |
|---|---|---|
| controls | Active comparator | phacoemulsification and IOL implantation Receives: Procedure: phacoemulsification of the lens |
| diabetic without pseudoexfoliation | Active comparator | phacoemulsification and IOL implantation Receives: Procedure: phacoemulsification of the lens |
| non-diabetic with pseudoexfoliation | Active comparator | phacoemulsification and IOL implantation Receives: Procedure: phacoemulsification of the lens |
| diabetic with pseudoexfoliation | Active comparator | phacoemulsification and IOL implantation Receives: Procedure: phacoemulsification of the lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial cell density
number of endothelial cells
Measured: 6 months
Percentage of hexagonal cells
indicator of healthy endothelial cells
Measured: 6 months
coefficient of variation (CV)
indicator of the uniformity of the size of endothelial cells
Measured: 6 months
Central corneal thickness
measurement of the distance between the epithelium and endothelium at the central cornea
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Dec 2020
- Primary completion12 Oct 2021
- Study completion16 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PseudoexfoliationStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Radi AttaAllah, Minia University
- Investigators
- Heba R AttaAllah, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965168
- Sponsor's protocol ID
- 691:11/2020
- Status last verified
- Nov 2021
- First submitted
- 7 Jul 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Storr-Paulsen A, Singh A, Jeppesen H, Norregaard JC, Thulesen J. Corneal endothelial morphology and central thickness in patients with type II diabetes mellitus. Acta Ophthalmol. 2014 Mar;92(2):158-60. doi: 10.1111/aos.12064. Epub 2013 Feb 7.
PubMed 23387877Fernandez-Munoz E, Zamora-Ortiz R, Gonzalez-Salinas R. Endothelial cell density changes in diabetic and nondiabetic eyes undergoing phacoemulsification employing phaco-chop technique. Int Ophthalmol. 2019 Aug;39(8):1735-1741. doi: 10.1007/s10792-018-0995-y. Epub 2018 Jul 28.
PubMed 30056522Oltulu R, Satirtav G, Kayitmazbatir ET, Bitirgen G, Ozkagnici A, Karaibrahimoglu A. Characteristics of the cornea in patients with pseudoexfoliation syndrome. Arq Bras Oftalmol. 2015 Nov-Dec;78(6):348-51. doi: 10.5935/0004-2749.20150092.
PubMed 26677035Aoki T, Kitazawa K, Inatomi T, Kusada N, Horiuchi N, Takeda K, Yokoi N, Kinoshita S, Sotozono C. Publisher Correction: Risk Factors for Corneal Endothelial Cell Loss in Patients with Pseudoexfoliation Syndrome. Sci Rep. 2020 May 26;10(1):8800. doi: 10.1038/s41598-020-66089-4.
PubMed 32451432Quiroga L, Lansingh VC, Samudio M, Pena FY, Carter MJ. Characteristics of the corneal endothelium and pseudoexfoliation syndrome in patients with senile cataract. Clin Exp Ophthalmol. 2010 Jul;38(5):449-55. doi: 10.1111/j.1442-9071.2010.02313.x. Epub 2010 Apr 28.
PubMed 20456430Mahmoud MSE, Omar IAN, AttaAllah HR. Evaluation of the corneal thickness and endothelial changes following uncomplicated phacoemulsification in diabetic and non-diabetic patients with pseudo-exfoliation syndrome by specular microscopy. Int Ophthalmol. 2023 Dec;43(12):4773-4780. doi: 10.1007/s10792-023-02877-x. Epub 2023 Sep 18.
PubMed 37721703
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corneal Endothelium Following Phacoemulsification in Diabetic and Non-diabetic Patients With Pseudoexfoliation Syndrome by Specular Microscopy
- ClinicalTrials.gov ID
- NCT04965168
- Acronym / sponsor ID
- 691:11/2020
- Conditions
- Pseudoexfoliation
- Keywords
- DM, phacoemulsification, endothelial cell density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 16 Oct 2021 (actual)
- First posted
- 16 Jul 2021 (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.
Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using specular microscopy.
Detailed description
Our study is a comparative study that included 4 groups (controls, patients with PEX, non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over a 6 months follow up period.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| controls | Active comparator | Procedure: phacoemulsification of the lensphacoemulsification and IOL implantation |
| diabetic without pseudoexfoliation | Active comparator | Procedure: phacoemulsification of the lensphacoemulsification and IOL implantation |
| non-diabetic with pseudoexfoliation | Active comparator | Procedure: phacoemulsification of the lensphacoemulsification and IOL implantation |
| diabetic with pseudoexfoliation | Active comparator | Procedure: phacoemulsification of the lensphacoemulsification and IOL implantation |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Senile cataract with age between 50 to 70 years
- Clear cornea with no zonuler dehiscence
- Lens opacity classification system III (LOCS III), with grade 2-3 nuclear cataract with any additional cortical (C) and posterior sub capsular (P)
Key exclusion criteria (6 listed)
- Uncontrolled DM in diabetic groups
- Presence of autoimmune diseases
- Patients with glaucoma
- Corneal guttata
- Zonular dehiscence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phacoemulsification of the lensall patients underwent phacoemulsification and IOL implantation for immature cataract extraction | Procedure or surgery | controls, diabetic with pseudoexfoliation, diabetic without pseudoexfoliation, non-diabetic with pseudoexfoliation |
Primary outcome
endothelial cell density
Time frame: 6 months
number of endothelial cells
Percentage of hexagonal cells
Time frame: 6 months
indicator of healthy endothelial cells
coefficient of variation (CV)
Time frame: 6 months
indicator of the uniformity of the size of endothelial cells
Central corneal thickness
Time frame: 6 months
measurement of the distance between the epithelium and endothelium at the central cornea
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 12 Nov 2021.
- Background: PubMed 23387877Storr-Paulsen A, Singh A, Jeppesen H, Norregaard JC, Thulesen J. Corneal endothelial morphology and central thickness in patients with type II diabetes mellitus. Acta Ophthalmol. 2014 Mar;92(2):158-60. doi: 10.1111/aos.12064. Epub 2013 Feb 7.
- Background: PubMed 30056522Fernandez-Munoz E, Zamora-Ortiz R, Gonzalez-Salinas R. Endothelial cell density changes in diabetic and nondiabetic eyes undergoing phacoemulsification employing phaco-chop technique. Int Ophthalmol. 2019 Aug;39(8):1735-1741. doi: 10.1007/s10792-018-0995-y. Epub 2018 Jul 28.
- Background: PubMed 26677035Oltulu R, Satirtav G, Kayitmazbatir ET, Bitirgen G, Ozkagnici A, Karaibrahimoglu A. Characteristics of the cornea in patients with pseudoexfoliation syndrome. Arq Bras Oftalmol. 2015 Nov-Dec;78(6):348-51. doi: 10.5935/0004-2749.20150092.
- Background: PubMed 32451432Aoki T, Kitazawa K, Inatomi T, Kusada N, Horiuchi N, Takeda K, Yokoi N, Kinoshita S, Sotozono C. Publisher Correction: Risk Factors for Corneal Endothelial Cell Loss in Patients with Pseudoexfoliation Syndrome. Sci Rep. 2020 May 26;10(1):8800. doi: 10.1038/s41598-020-66089-4.
- Background: PubMed 20456430Quiroga L, Lansingh VC, Samudio M, Pena FY, Carter MJ. Characteristics of the corneal endothelium and pseudoexfoliation syndrome in patients with senile cataract. Clin Exp Ophthalmol. 2010 Jul;38(5):449-55. doi: 10.1111/j.1442-9071.2010.02313.x. Epub 2010 Apr 28.
- Derived from this study: PubMed 37721703Mahmoud MSE, Omar IAN, AttaAllah HR. Evaluation of the corneal thickness and endothelial changes following uncomplicated phacoemulsification in diabetic and non-diabetic patients with pseudo-exfoliation syndrome by specular microscopy. Int Ophthalmol. 2023 Dec;43(12):4773-4780. doi: 10.1007/s10792-023-02877-x. Epub 2023 Sep 18.
- Individual participant dataSharing planned: No
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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.
Heba R AttaAllah, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification of the lens in people with Pseudoexfoliation, run by Minia University at 1 site in Egypt.
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 3 inclusion and 6 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 12 Nov 2021. 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 Egypt. 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?
endothelial cell density (time frame: 6 months). The study lists 4 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 NCT04965168, which also lists 6 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 12 Nov 2021.