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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Astigmatism of Both Eyes

Intervention / Treatment
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* Procedure: Planned incisions during phacoemulsification


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized into experimental and controlled groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A:experimental group<br>those who receive planned incisions | Procedure: Planned incisions during phacoemulsification<br>* 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<br>|
| Active Comparator: Group B:Controlled group<br>the patients who were operated by conventional phacoemulsification | Procedure: Planned incisions during phacoemulsification<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Astigmatism. phacoemulsification, corneal incision