Evidence map›Paper›PMID 38388956›Full record

Trial reportTrials2024

Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial.

Soujanya Kaup, Dimple Kondal, Siddharudha Shivalli, John Buchan

Open access · goldAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 3 countries.

Soujanya Kaup *Department of Ophthalmology, Yenepoya Medical College Hospital, Yenepoya Deemed to be University, Mangalore, Karnataka, 575018, India. drsoujanyak@gmail.com.ORCID http://orcid.org/0000-0002-5908-5921
Dimple Kondal *Centre for Chronic Disease Control, Safdarjung Development Area, C-1/52, Second Floor, Delhi, 110016, India.
Siddharudha ShivalliDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
John BuchanInternational Centre for Eye Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Emory University · USLondon School of Hygiene & Tropical Medicine · GBUniversity of London · GBYenepoya University · IN

Funding

DBT-Wellcome Trust India Alliance IA/CPHE/17/1/503337
6 · The paper itself

Abstract

backgroundCornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with predisposing factors. The role of phaco tip position during phacoemulsification on corneal endothelial damage is ambiguous, and there is no consensus regarding the most cornea-friendly phaco tip position (bevel-up or bevel-down). The objective of the trial is to compare the effect of phaco tip position (bevel-up vs. bevel-down) during phacoemulsification using direct chop technique on corneal endothelial cell count. METHODS AND

designTIPS is a randomised, multicentre, parallel-group, triple-masked (participant, outcome assessor, and statistician) trial with 1:1 allocation ratio. A total of 480 eligible participants, aged > 18 years with immature cataract, will be randomly allocated into bevel-up and bevel-down groups at two centres. Randomisation will be stratified according to the cataract grade. The primary outcome is postoperative endothelial cell count at 1 month. Secondary outcomes are central corneal thickness on postoperative days 1, 15, and 30 and difference in intraoperative complications.

conclusionIn this paper, we describe the detailed statistical analysis plan (SAP) for the TIPS trial, which was prepared prior to database lock. The SAP includes details of planned analyses and unpopulated tables, which will be reported in the publications. We plan to lock the database in July 2023 and publish the results later in the same year. SAP Version 0.1 (dated: 28 April 2023) Protocol version:2.0

trial registrationClinical Trial Registry of India CTRI/2019/02/017464. Registered on 5 February 2019; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=29764&EncHid=&userName=2019/02/017464.

Indexed as

CataractPhacoemulsificationCell CountCorneaHumansProspective StudiesVisual AcuityBevel-downBevel-upEndothelial cell lossPhacoemulsificationPhacoemulsification/complicationPhaco-tipPseudophakic bullous keratopathySpecular microscopy

Identifiers

PMID38388956
PMCPMC10882898
OpenAlexW4392054011

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.