Astigmatism of Both EyesNCT05457348
Effect of Single Incision Versus Three Planned Incisions to Reduce Pre-operative Astigmatism After Phacoemulsification.
A study testing Planned incisions during phacoemulsification in people with Astigmatism of Both Eyes, run by Suleman Roshan Medical College at 1 site in Pakistan.
Trial summary
Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Astigmatism of Both Eyes
- What is being tested?
- Planned incisions during phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jul 2022to 2 Mar 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1. Previous ocular surgery. 2. previous ocular trauma. 3. Pre-existing ocular disease. 4. High intraocular pressure (IOP) 5. Corneal opacity. 6. Strabismus 7. Amblyopia 8. Diabetes mellitus 9. Irregular astigmatism.
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Suleman Roshan Medical College Hospital
Tando Adam, Sindh, 68050
Jamshad Ahmed, FCPS, 03332441746
About this study
Official title: Effect of Single Incision Versus Three Planned Incision to Reduce Pre-operative Astigmatism After Phacoemulsification.
Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a monofocal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism4. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide)
Read the detailed description
According to the 2020 estimate, 33·6 million adults aged 50 years and older were blind with cataracts as a leading cause (15·2 million cases). According to Pakistan national blindness survey, cataract is the leading cause of blindness in Pakistan. Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a mono-focal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide). Our study aims to compare the results of phacoemulsification cataract surgery with a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) with convention supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism. We hypothesize that a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) is better than conventional supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism at a significant level of 0.05.
- Conditions
- Astigmatism of Both Eyes
- Being tested
- Planned incisions during phacoemulsification
- Keywords
- Astigmatism. phacoemulsification, corneal incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned incisions during phacoemulsificationProcedure or surgery
Planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian will be performed in the experimental group during phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| Group A:experimental group | Experimental | those who receive planned incisions Receives: Procedure: Planned incisions during phacoemulsification |
| Group B:Controlled group | Active comparator | the patients who were operated by conventional phacoemulsification Receives: Procedure: Planned incisions during phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Astigmatism
Postoperative reduction in astigmatism after phacoemulsification.
Measured: Patients will be assessed at first postoperative day then after one month , three months and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start30 Jul 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion2 Mar 2023 (estimated)
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 Astigmatism of Both EyesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into experimental and controlled groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleman Roshan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamshad Ahmed, Suleman Roshan Medical College
- Investigators
- Jamshad Ahmed, FCPS, Principal investigator, Suleman Roshan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457348
- Sponsor's protocol ID
- Corneal incision & Astigmatism
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the clinical study report will be shared with all participants if they desire. the study will be published in a journal. it will be available to all participants and the research community.
Publications
GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1.
PubMed 33275949Dineen B, Bourne RR, Jadoon Z, Shah SP, Khan MA, Foster A, Gilbert CE, Khan MD; Pakistan National Eye Survey Study Group. Causes of blindness and visual impairment in Pakistan. The Pakistan national blindness and visual impairment survey. Br J Ophthalmol. 2007 Aug;91(8):1005-10. doi: 10.1136/bjo.2006.108035. Epub 2007 Jan 17.
PubMed 17229806Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25.
PubMed 28242111Day AC, Dhariwal M, Keith MS, Ender F, Perez Vives C, Miglio C, Zou L, Anderson DF. Distribution of preoperative and postoperative astigmatism in a large population of patients undergoing cataract surgery in the UK. Br J Ophthalmol. 2019 Jul;103(7):993-1000. doi: 10.1136/bjophthalmol-2018-312025. Epub 2018 Sep 6.
PubMed 30190365Ren Y, Fang X, Fang A, Wang L, Jhanji V, Gong X. Phacoemulsification With 3.0 and 2.0 mm Opposite Clear Corneal Incisions for Correction of Corneal Astigmatism. Cornea. 2019 Sep;38(9):1105-1110. doi: 10.1097/ICO.0000000000001915.
PubMed 30844842What is current GDP of Pakistan?. Paid for articles.com. naeemofficial3; Jun 19, 2022
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Incision Versus Three Planned Incision to Reduce Pre-operative Astigmatism After Phacoemulsification.
- ClinicalTrials.gov ID
- NCT05457348
- Acronym / sponsor ID
- Corneal incision & Astigmatism
- Conditions
- Astigmatism of Both Eyes
- Keywords
- Astigmatism. phacoemulsification, corneal incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Suleman Roshan Medical CollegeUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 14 Jul 2022 (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.
Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a monofocal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism4. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide)
Detailed description
According to the 2020 estimate, 33·6 million adults aged 50 years and older were blind with cataracts as a leading cause (15·2 million cases). According to Pakistan national blindness survey, cataract is the leading cause of blindness in Pakistan. Cataract surgery by phacoemulsification is the most commonly performed procedure in Pakistan. Cataract surgery aims for visual rehabilitation and freedom from all kinds of eyewear. Pre-operative corneal astigmatism greater than 1.0 Diopter is reported in 42% preoperatively and 58%postoperatively after implanting a mono-focal intraocular lens(IOL). Visual acuity tended to worsen postoperatively with increased astigmatism. Different treatment modalities are used to reduce astigmatism, like toric IOL. Limbal relaxing incision, actuate keratotomy, intrastromal rings, Lasik and femtosecond laser. Most of these modalities are expensive, so they cannot be afforded by the patients as Pakistan is a low-income country with a per capita income of US$1,562 (160th worldwide). Our study aims to compare the results of phacoemulsification cataract surgery with a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) with convention supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism. We hypothesize that a planned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian incisions ( group A) is better than conventional supero-temporal 2.8 mm clear corneal incision(Group B) for the correction of postoperative astigmatism at a significant level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized into experimental and controlled groups
| Arm | Type | Receives |
|---|---|---|
| Group A:experimental group | Experimental | Procedure: Planned incisions during phacoemulsificationthose who receive planned incisions |
| Group B:Controlled group | Active comparator | Procedure: Planned incisions during phacoemulsificationthe patients who were operated by conventional phacoemulsification |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 1. Previous ocular surgery. 2. previous ocular trauma. 3. Pre-existing ocular disease. 4. High intraocular pressure (IOP) 5. Corneal opacity. 6. Strabismus 7. Amblyopia 8. Diabetes mellitus 9. Irregular astigmatism.
- -
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 |
|---|---|---|
| Planned incisions during phacoemulsificationPlanned three (one 2.8 mm and two 2.0mm) on the or near to steep meridian will be performed in the experimental group during phacoemulsification | Procedure or surgery | Group A:experimental group, Group B:Controlled group |
Primary outcome
Reduction in Astigmatism
Time frame: Patients will be assessed at first postoperative day then after one month , three months and six months.
Postoperative reduction in astigmatism after phacoemulsification.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Results publication: PubMed 33275949GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1.
- Results publication: PubMed 17229806Dineen B, Bourne RR, Jadoon Z, Shah SP, Khan MA, Foster A, Gilbert CE, Khan MD; Pakistan National Eye Survey Study Group. Causes of blindness and visual impairment in Pakistan. The Pakistan national blindness and visual impairment survey. Br J Ophthalmol. 2007 Aug;91(8):1005-10. doi: 10.1136/bjo.2006.108035. Epub 2007 Jan 17.
- Results publication: PubMed 28242111Liu YC, Wilkins M, Kim T, Malyugin B, Mehta JS. Cataracts. Lancet. 2017 Aug 5;390(10094):600-612. doi: 10.1016/S0140-6736(17)30544-5. Epub 2017 Feb 25.
- Results publication: PubMed 30190365Day AC, Dhariwal M, Keith MS, Ender F, Perez Vives C, Miglio C, Zou L, Anderson DF. Distribution of preoperative and postoperative astigmatism in a large population of patients undergoing cataract surgery in the UK. Br J Ophthalmol. 2019 Jul;103(7):993-1000. doi: 10.1136/bjophthalmol-2018-312025. Epub 2018 Sep 6.
- Results publication: PubMed 30844842Ren Y, Fang X, Fang A, Wang L, Jhanji V, Gong X. Phacoemulsification With 3.0 and 2.0 mm Opposite Clear Corneal Incisions for Correction of Corneal Astigmatism. Cornea. 2019 Sep;38(9):1105-1110. doi: 10.1097/ICO.0000000000001915.
- Results publicationWhat is current GDP of Pakistan?. Paid for articles.com. naeemofficial3; Jun 19, 2022
- link for first referenceLink provided by the sponsor.
- link for second referenceLink provided by the sponsor.
- link for third referenceLink provided by the sponsor.
- link for fifth referenceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. the clinical study report will be shared with all participants if they desire. the study will be published in a journal. it will be available to all participants and the research community.
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.
Jamshad Ahmed, FCPS principal investigator
Suleman Roshan Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planned incisions during phacoemulsification in people with Astigmatism of Both Eyes, run by Suleman Roshan Medical College at 1 site in Pakistan.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamshad Ahmed, FCPS (03332441746, jamshikhan1962@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Astigmatism (time frame: Patients will be assessed at first postoperative day then after one month , three months and six months.). 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 NCT05457348, 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 14 Jul 2022.