Senile CataractNCT03262285
Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction
An observational study of Senile Cataract, run by Assiut University at 1 site in Egypt.
Trial summary
the investigators will compare between the endothelial cell loss after phacoemulsification and extracapsular cataract extraction in management of senile cataract Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Senile Cataract
- What is being tested?
- phacoemulsification and extracapsular cataract extraction
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 15 Jan 2021
- 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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with senile cataract
Who may be able to join
- Cases of senile cataract of both sexes will be included in this study
Who cannot join
- Corneal endothelial pathologies such as Fuch's dystrophy
- Complicated cataract
- Cataract with history of trauma
- Coexisting eye pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction in Management of Senile Cataract
the investigators will compare between the endothelial cell loss after phacoemulsification and extracapsular cataract extraction in management of senile cataract
Read the detailed description
Age related cataract is believed to be the main cause of reversible blindness worldwide and in developing countries. Population-based studies have reported that cataract is responsible for 47.8% to 51% of all global blindness.
Several studies compared phacoemulsification and conventional extracapsular cataract extraction regarding several aspects such as postoperative inflammation and visual rehabilitation. studies proved that phacoemulsification has faster rehabilitation ,less astigmatism and better postoperative vision .However, Extracapsular cataract extraction is still the operation of choice in some cataract cases.
The normal corneal endothelium is a single layer of uniformly sized cells with a predominantly hexagonal shape. Adult density of approximately 2400 - 3200 cells/mm².The number of cells decreases at about 0.6% per year and neighbouring cells enlarge to fill the space as the cells cannot regenerate.The minimum cell density necessary for adequate function is in the range of 400 to 700 cells/mm2.
The effect of cataract surgery on corneal endothelium is an important factor that affects postoperative vision .However, it is accepted all over the world that there is definite loss of some endothelial cells with all techniques of cataract surgery. Previously, cataract surgery caused enormous loss of endothelial cells , but with enhancement of equipment and surgical techniques, cataract surgery today results in 6-14%loss of endothelial cells.
Specular microscopy is a noninvasive photographic technique that allows visualization and analysis of corneal endothelium. specular microscopy is used to show cell count and cell shape in the scanned area.
- Conditions
- Senile Cataract
- Being tested
- phacoemulsification, extracapsular cataract extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationProcedure or surgery
removal of cataract using ultrasound waves
extracapsular cataract extractionProcedure or surgery
removal of cataract using surgical corneal incision
| Study group | Role | What they receive |
|---|---|---|
| phacoemulsification | patients undergoing phacoemulsification surgery for senile cataract Receives: Procedure: phacoemulsification | |
| extracapsular cataract extraction | patients undergoing extracapsular cataract extraction surgery for senile cataract Receives: Procedure: extracapsular cataract extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of endothelial cell loss
specular microscopy will be done to measure the endothelial cell count before and after the intervention to measure the percentage of loss
Measured: 5 minutes
Secondary outcomes (1)
changes in shape of endothelial cell
specular microscopy will be done to identify changes in hexagonality of endothelial cells after the intervention
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Jul 2018
- Primary completion1 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Senile CataractStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawda Abdelnaser, Assiut University
- Investigators
- Ali Ryad, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262285
- Sponsor's protocol ID
- CECLPEECCE
- Status last verified
- May 2020
- First submitted
- 23 Aug 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lundstrom M, Goh PP, Henry Y, Salowi MA, Barry P, Manning S, Rosen P, Stenevi U. The changing pattern of cataract surgery indications: a 5-year study of 2 cataract surgery databases. Ophthalmology. 2015 Jan;122(1):31-8. doi: 10.1016/j.ophtha.2014.07.047. Epub 2014 Sep 16.
PubMed 25234011Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.
PubMed 25104599Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
PubMed 15640920Wang W, Yan W, Muller A, He M. A Global View on Output and Outcomes of Cataract Surgery With National Indices of Socioeconomic Development. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3669-3676. doi: 10.1167/iovs.17-21489.
PubMed 28728174Gogate PM, Kulkarni SR, Krishnaiah S, Deshpande RD, Joshi SA, Palimkar A, Deshpande MD. Safety and efficacy of phacoemulsification compared with manual small-incision cataract surgery by a randomized controlled clinical trial: six-week results. Ophthalmology. 2005 May;112(5):869-74. doi: 10.1016/j.ophtha.2004.11.055.
PubMed 15878068Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997 Mar;38(3):779-82.
PubMed 9071233Bourne RR, Minassian DC, Dart JK, Rosen P, Kaushal S, Wingate N. Effect of cataract surgery on the corneal endothelium: modern phacoemulsification compared with extracapsular cataract surgery. Ophthalmology. 2004 Apr;111(4):679-85. doi: 10.1016/j.ophtha.2003.07.015.
PubMed 15051198Trnavec B, Cuvala J, Cernak A, Vodrazkova E. [Comparison of corneal endothelial cells after ECCE and phacoemulsification of the lens]. Cesk Slov Oftalmol. 1997 Aug;53(4):240-3. Slovak.
PubMed 9377317
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction in Management of Senile Cataract
- ClinicalTrials.gov ID
- NCT03262285
- Acronym / sponsor ID
- CECLPEECCE
- Conditions
- Senile Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 25 Aug 2017 (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.
the investigators will compare between the endothelial cell loss after phacoemulsification and extracapsular cataract extraction in management of senile cataract
Detailed description
Age related cataract is believed to be the main cause of reversible blindness worldwide and in developing countries. Population-based studies have reported that cataract is responsible for 47.8% to 51% of all global blindness.
Several studies compared phacoemulsification and conventional extracapsular cataract extraction regarding several aspects such as postoperative inflammation and visual rehabilitation. studies proved that phacoemulsification has faster rehabilitation ,less astigmatism and better postoperative vision .However, Extracapsular cataract extraction is still the operation of choice in some cataract cases.
The normal corneal endothelium is a single layer of uniformly sized cells with a predominantly hexagonal shape. Adult density of approximately 2400 - 3200 cells/mm².The number of cells decreases at about 0.6% per year and neighbouring cells enlarge to fill the space as the cells cannot regenerate.The minimum cell density necessary for adequate function is in the range of 400 to 700 cells/mm2.
The effect of cataract surgery on corneal endothelium is an important factor that affects postoperative vision .However, it is accepted all over the world that there is definite loss of some endothelial cells with all techniques of cataract surgery. Previously, cataract surgery caused enormous loss of endothelial cells , but with enhancement of equipment and surgical techniques, cataract surgery today results in 6-14%loss of endothelial cells.
Specular microscopy is a noninvasive photographic technique that allows visualization and analysis of corneal endothelium. specular microscopy is used to show cell count and cell shape in the scanned area.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phacoemulsification | – | Procedure: phacoemulsificationpatients undergoing phacoemulsification surgery for senile cataract |
| extracapsular cataract extraction | – | Procedure: extracapsular cataract extractionpatients undergoing extracapsular cataract extraction surgery for senile cataract |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with senile cataract
Key inclusion criteria (1 listed)
- Cases of senile cataract of both sexes will be included in this study
Key exclusion criteria (4 listed)
- Corneal endothelial pathologies such as Fuch's dystrophy
- Complicated cataract
- Cataract with history of trauma
- Coexisting eye pathology
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 |
|---|---|---|
| phacoemulsificationremoval of cataract using ultrasound waves | Procedure or surgery | phacoemulsification |
| extracapsular cataract extractionremoval of cataract using surgical corneal incision | Procedure or surgery | extracapsular cataract extraction |
Primary outcome
percentage of endothelial cell loss
Time frame: 5 minutes
specular microscopy will be done to measure the endothelial cell count before and after the intervention to measure the percentage of loss
1 secondary outcome
changes in shape of endothelial cell
Time frame: 5 minutes
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 27 Jan 2021.
- Background: PubMed 25234011Lundstrom M, Goh PP, Henry Y, Salowi MA, Barry P, Manning S, Rosen P, Stenevi U. The changing pattern of cataract surgery indications: a 5-year study of 2 cataract surgery databases. Ophthalmology. 2015 Jan;122(1):31-8. doi: 10.1016/j.ophtha.2014.07.047. Epub 2014 Sep 16.
- Background: PubMed 25104599Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.
- Background: PubMed 15640920Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
- Background: PubMed 28728174Wang W, Yan W, Muller A, He M. A Global View on Output and Outcomes of Cataract Surgery With National Indices of Socioeconomic Development. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3669-3676. doi: 10.1167/iovs.17-21489.
- Background: PubMed 15878068Gogate PM, Kulkarni SR, Krishnaiah S, Deshpande RD, Joshi SA, Palimkar A, Deshpande MD. Safety and efficacy of phacoemulsification compared with manual small-incision cataract surgery by a randomized controlled clinical trial: six-week results. Ophthalmology. 2005 May;112(5):869-74. doi: 10.1016/j.ophtha.2004.11.055.
- Background: PubMed 9071233Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997 Mar;38(3):779-82.
- Background: PubMed 15051198Bourne RR, Minassian DC, Dart JK, Rosen P, Kaushal S, Wingate N. Effect of cataract surgery on the corneal endothelium: modern phacoemulsification compared with extracapsular cataract surgery. Ophthalmology. 2004 Apr;111(4):679-85. doi: 10.1016/j.ophtha.2003.07.015.
- Background: PubMed 9377317Trnavec B, Cuvala J, Cernak A, Vodrazkova E. [Comparison of corneal endothelial cells after ECCE and phacoemulsification of the lens]. Cesk Slov Oftalmol. 1997 Aug;53(4):240-3. Slovak.
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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.
Ali Ryad, professor study chair
Assiut University
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 Senile Cataract, run by Assiut 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 1 inclusion and 4 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 27 Jan 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?
percentage of endothelial cell loss (time frame: 5 minutes). 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 NCT03262285, which also lists 8 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 27 Jan 2021.