Effect of Single Incision Versus Three Planned Incisions to Reduce Pre-operative Astigmatism After Phacoemulsification.
1 other identifier
interventional
160
1 country
1
Brief 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. 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedStudy Start
First participant enrolled
July 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2023
CompletedJuly 14, 2022
July 1, 2022
5 months
July 11, 2022
July 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in Astigmatism
Postoperative reduction in astigmatism after phacoemulsification.
Patients will be assessed at first postoperative day then after one month , three months and six months.
Study Arms (2)
Group A:experimental group
EXPERIMENTALthose who receive planned incisions
Group B:Controlled group
ACTIVE COMPARATORthe patients who were operated by conventional phacoemulsification
Interventions
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
Eligibility Criteria
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suleman Roshan Medical College Hospital
Tando Adam, Sindh, 68050, Pakistan
Related Publications (6)
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.
PMID: 33275949RESULTDineen 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.
PMID: 17229806RESULTLiu 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.
PMID: 28242111RESULTDay 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.
PMID: 30190365RESULTRen 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.
PMID: 30844842RESULTWhat is current GDP of Pakistan?. Paid for articles.com. naeemofficial3; Jun 19, 2022
RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jamshad Ahmed, FCPS
Suleman Roshan Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The patient will be selected and randomized into two groups after obtaining informed consent. patient will not know about the intervention
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 11, 2022
First Posted
July 14, 2022
Study Start
July 30, 2022
Primary Completion
December 30, 2022
Study Completion
March 2, 2023
Last Updated
July 14, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- after 6 months
- Access Criteria
- contact with principal investigator
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.