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Effect of Single Incision Versus Three Planned Incisions to Reduce Pre-operative Astigmatism After Phacoemulsification.

Primary Purpose

Astigmatism of Both Eyes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Planned incisions during phacoemulsification
Sponsored by
Suleman Roshan Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism of Both Eyes focused on measuring Astigmatism. phacoemulsification, corneal incision

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cataract patients aged between 50 and 80 years having 1.0 diopters (D) or greater of regular corneal astigmatism documented by keratometry.

Exclusion Criteria:

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.

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Sites / Locations

  • Suleman Roshan Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A:experimental group

Group B:Controlled group

Arm Description

those who receive planned incisions

the patients who were operated by conventional phacoemulsification

Outcomes

Primary Outcome Measures

Reduction in Astigmatism
Postoperative reduction in astigmatism after phacoemulsification.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2022
Last Updated
July 11, 2022
Sponsor
Suleman Roshan Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05457348
Brief Title
Effect of Single Incision Versus Three Planned Incisions to Reduce Pre-operative Astigmatism After Phacoemulsification.
Official Title
Effect of Single Incision Versus Three Planned Incision to Reduce Pre-operative Astigmatism After Phacoemulsification.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
March 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleman Roshan Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism of Both Eyes
Keywords
Astigmatism. phacoemulsification, corneal incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized into experimental and controlled groups
Masking
Participant
Masking Description
The patient will be selected and randomized into two groups after obtaining informed consent. patient will not know about the intervention
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A:experimental group
Arm Type
Experimental
Arm Description
those who receive planned incisions
Arm Title
Group B:Controlled group
Arm Type
Active Comparator
Arm Description
the patients who were operated by conventional phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
Planned incisions during phacoemulsification
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction in Astigmatism
Description
Postoperative reduction in astigmatism after phacoemulsification.
Time Frame
Patients will be assessed at first postoperative day then after one month , three months and six months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cataract patients aged between 50 and 80 years having 1.0 diopters (D) or greater of regular corneal astigmatism documented by keratometry. Exclusion Criteria: 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamshad Ahmed, FCPS
Phone
03332441746
Email
jamshikhan1962@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamshad Ahmed, FCPS
Organizational Affiliation
Suleman Roshan Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suleman Roshan Medical College Hospital
City
Tando Adam
State/Province
Sindh
ZIP/Postal Code
68050
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamshad Ahmed, FCPS
Phone
03332441746

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
after 6 months
IPD Sharing Access Criteria
contact with principal investigator
Citations:
PubMed Identifier
33275949
Citation
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. Erratum In: Lancet Glob Health. 2021 Apr;9(4):e408.
Results Reference
result
PubMed Identifier
17229806
Citation
Dineen 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 Reference
result
PubMed Identifier
28242111
Citation
Liu 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 Reference
result
PubMed Identifier
30190365
Citation
Day 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 Reference
result
PubMed Identifier
30844842
Citation
Ren 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 Reference
result
Citation
What is current GDP of Pakistan?. Paid for articles.com. naeemofficial3; Jun 19, 2022
Results Reference
result
Links:
URL
https://doi.org/10.1016/s2214-109x(20)30489-7
Description
link for first reference
URL
https://doi.org/10.1136/bjo.2006.108035
Description
link for second reference
URL
https://doi.org/10.1016/s0140-6736(17)30544-5
Description
link for third reference
URL
https://doi.org/10.1097/ico.0000000000001915
Description
link for fifth reference

Learn more about this trial

Effect of Single Incision Versus Three Planned Incisions to Reduce Pre-operative Astigmatism After Phacoemulsification.

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